## Protocol Section
### Identification Module
**NCT ID:** NCT00432679

**Brief Title:** A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

**Official Title:** Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -

#### Organization Study ID Info
**ID:** AVD105248
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2007-03-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-12

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-03-28

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-02-08

**Type:** ACTUAL

**Results First Submit Date:** 2017-08-24

**Results First Submit QC Date:** 2018-08-30

#### Start Date
**Date:** 2006-05-24

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2007-02-08
**Type:** ESTIMATED
**Study First Submit Date:** 2007-02-06
**Study First Submit QC Date:** 2007-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

**Keywords:**

- rosiglitazone

- Avandia

- type 2 diabetes mellitus

- diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 149

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** study drug

**Intervention Names:**

- Drug: Rosiglitazone (BRL49653C)

**Label:** arm 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- arm 1

**Description:** study drug

**Name:** Rosiglitazone (BRL49653C)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).

**Measure:** Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group

**Time Frame:** Baseline (Day 0) and Week 16

#### Secondary Outcomes

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Fasting Insulin

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Adiponectin

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

**Measure:** Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)

**Time Frame:** Baseline (Day 0) and Week 16

**Description:** The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.

**Measure:** Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment

**Time Frame:** Up to Week 16

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

* Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 212-0024

**Location 2:**

**City:** Kumamoto

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 862-0976

**Location 3:**

**City:** Oita

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 870-0039

**Location 4:**

**Facility:** GSK Investigational Site

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### Available IPDs

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Dataset Specification

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Individual Participant Data Set

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Clinical Study Report

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Annotated Case Report Form

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Statistical Analysis Plan

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Informed Consent Form

**URL:** https://www.clinicalstudydatarequest.com

**Comment:** For additional information about this study please refer to the GSK Clinical Study Register

**ID:** AVD105248

**Type:** Study Protocol

**URL:** https://www.clinicalstudydatarequest.com

#### References

**Citation:** This study has not been published in the scientific literature.

#### See Also Links

**Label:** Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

**URL:** https://www.clinicalstudydatarequest.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hypo

- Name: Hypoglycemic Agents

### Intervention Browse Module - Browse Leaves

- ID: M1804

- Name: Carbamide Peroxide

- Relevance: LOW

- As Found: Unknown

- ID: M245808

- Name: Maleic acid

- Relevance: LOW

- As Found: Unknown

- ID: M1677

- Name: Rosiglitazone

- Relevance: HIGH

- As Found: Telemedicine

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077154

- Term: Rosiglitazone

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Full analysis set was used for reporting non-SAE and SAE.

#### Event Groups

**Group ID:** EG000

**Title:** Rosiglitazone 4 mg Orally Once Daily

**Deaths Num At Risk:** 74

**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.

**ID:** EG000

**Other Num Affected:** 61

**Other Num at Risk:** 74

**Serious Number Affected:** 1

**Serious Number At Risk:** 74

**Title:** Rosiglitazone 4 mg Orally Once Daily

**Group ID:** EG001

**Title:** Placebo

**Deaths Num At Risk:** 75

**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.

**ID:** EG001

**Other Num Affected:** 53

**Other Num at Risk:** 75

**Serious Number Affected:** 1

**Serious Number At Risk:** 75

**Title:** Placebo

**Frequency Threshold:** 0

#### Other Events

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood triglyccrides increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood pressure increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Brain natriuretic peptide increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood cholesterol increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Urine ketone body present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood urine present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Hjgh density lipoprotein decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Low density lipoprotein increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Protein urine present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood albumin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood uric acid increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Liver function test abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Monocyte count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Neutrophll count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Reticulocyte count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** White blood cell count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Hordeolum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Bronchitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Chronic sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Gastrointestinal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Herpes simplex

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Impetigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** lnfluenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Reflux ocsophagitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Stomach discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Periodontitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Anal fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Dental caries

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Gastric ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Hiatus hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Toothache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Duodenal scarring

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Epigastric discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Upper respiratory tract inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Rhinitis allergic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Pharyngolaryngeal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version

**Term:** Tenosynovitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Musculoskeletal stiffness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Joint contracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Myajgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Osteoporosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Joint range of motion decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Limb discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Feeling abnonnal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Thirst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Animal bite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Arthropod sting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Back injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Epicondylitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Tooth injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Thennal bum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Neck injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Tooth fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Hypoaesthcsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Areflexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Carotid artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Sciatica

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Tension headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Dermatitis contact

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Corneal epithelium disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Diabetic retinopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Lacrimation increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Punctate keratitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Corneal exfoliation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version

**Term:** Anxiety disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version

**Term:** Bundle branch block right

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version

**Term:** Extrasystoles

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version

**Term:** Hepatic steatosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version

**Term:** Hyperaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version

**Term:** Pollakiuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version

**Term:** Urinary retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version

**Term:** Ear discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA version

**Term:** Adrenal mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA version

**Term:** Uterine polyp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA version

#### Serious Events

**Term:** Liposacromal recurrent

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA version

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 74

**Group ID:** EG001

**Num At Risk:** 75

**Term:** Brain stem infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version

##### Stats

**Group ID:** EG000

**Num At Risk:** 74

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 75

**Time Frame:** All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 74

**Group ID:** BG001

**Value:** 75

**Group ID:** BG002

**Value:** 149

**Units:** Participants

### Group

**ID:** BG000

**Title:** Rosiglitazone 4 mg Orally Once Daily

**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.81

**Value:** 60.1

#### Measurement

**Group ID:** BG001

**Spread:** 9.80

**Value:** 61.6

#### Measurement

**Group ID:** BG002

**Spread:** 9.32

**Value:** 60.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 55

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 47

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 94

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 74

#### Measurement

**Group ID:** BG001

**Value:** 75

#### Measurement

**Group ID:** BG002

**Value:** 149

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** GlaxoSmithKline
**Phone:** 866-435-7343
**Title:** GSK Response Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -1.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.61
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.102
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -0.81
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -32.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -12.1
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 5.06
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -22.1
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.883
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.319
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.8102
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.377
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 0.718
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -6.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.09
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.094
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.330
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -2.04
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.945
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.925
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.4730
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.983
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -0.010
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 1.191
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 15.248
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.5560
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.022
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 8.220
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 6.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9.91
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.860
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 8.21
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -0.05
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.355
**Estimate Comment:** Comparison of leptin.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.069
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 0.65
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -2477.7
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 700.1
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 803.96
**Estimate Comment:** Comparison of hs-CRP
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.271
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -888.8
**Statistical Comment:** 
**Statistical Method:** Unpaired t-test
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 27.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 54.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of HbA1c, decrease by 0.7%
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 40.6
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 13.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of HbA1c, fell below 6.5%
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.8
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 27.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 54.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of HbA1c, satisfied either 1 or 2
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 40.6
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 9.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 36.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of FPG, decrease of 30 milligrams per decilliter
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 23.1
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -5.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 18.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of FPG, fell below 126 milligrams per deciliter
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.9
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 5.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 35.3
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Comparison of FPG, satisfied either 1 or 2
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 20.5
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.074
- **Upper Limit:** 
- **Value:** -0.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.073
- **Upper Limit:** 
- **Value:** 0.19
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 28.91
- **Upper Limit:** 
- **Value:** -15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 32.69
- **Upper Limit:** 
- **Value:** 6.2
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2699
- **Upper Limit:** 
- **Value:** -0.479
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.1434
- **Upper Limit:** 
- **Value:** -1.197
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13.630
- **Upper Limit:** 
- **Value:** -1.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.666
- **Upper Limit:** 
- **Value:** 0.40
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.5562
- **Upper Limit:** 
- **Value:** -0.496
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.7556
- **Upper Limit:** 
- **Value:** -0.486
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.7875
- **Upper Limit:** 
- **Value:** 3.776
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.0408
- **Upper Limit:** 
- **Value:** -4.444
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.030
- **Upper Limit:** 
- **Value:** 9.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.301
- **Upper Limit:** 
- **Value:** 0.98
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.751
- **Upper Limit:** 
- **Value:** 0.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.332
- **Upper Limit:** 
- **Value:** -0.07
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5376.91
- **Upper Limit:** 
- **Value:** -189.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4349.58
- **Upper Limit:** 
- **Value:** 699.7
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.7
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
**Type:** PRIMARY
**Unit of Measure:** Percentage of Glycosylated Hemoglobin
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
**Type:** SECONDARY
**Unit of Measure:** Mg per decilliter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
**Type:** SECONDARY
**Unit of Measure:** Microunits per millilliter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
**Type:** SECONDARY
**Unit of Measure:** Picomoles per millilliter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
**Type:** SECONDARY
**Unit of Measure:** MilliUnit per liter*millimoles per liter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
**Type:** SECONDARY
**Unit of Measure:** Percentage of normal beta cells function
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Adiponectin
**Type:** SECONDARY
**Unit of Measure:** Micrograms per millilliter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set used. Only those participants available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) and Week 16
**Title:** Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
**Type:** SECONDARY
**Unit of Measure:** Nanograms per millilliter
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set used.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 16
**Title:** Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
##### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 milligrams (mg) tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** FG000
**Title:** Rosiglitazone 4 mg Orally Once Daily
#### Group
**Description:** Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 74
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 75
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 69
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 72
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Pre-Assignment Details:** Out of 172 participants given consent to participate in the study, 23 participants were withdrawn from the study before randomization.
**Recruitment Details:** From 19 April 2006 to 28 March 2007, total of 149 participants were randomized at 22 centers in Japan.
**Has Results:** True