## Protocol Section
### Identification Module
**NCT ID:** NCT00359879

**Brief Title:** Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

**Official Title:** Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

#### Organization Study ID Info
**ID:** H8O-CR-GWBH
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2007-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-02-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-02-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-07

**Type:** ACTUAL

#### Start Date
**Date:** 2006-09

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2006-08-03
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-01
**Study First Submit QC Date:** 2006-08-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

### Conditions Module

**Conditions:**

- Type 2 Diabetes

**Keywords:**

- diabetes

- exenatide

- Lilly

- Amylin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 377

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: exenatide

**Label:** 1 - exenatide before breakfast and dinner

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: exenatide

**Label:** 2 - exenatide before lunch and dinner

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 2 - exenatide before lunch and dinner

**Description:** subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)

**Name:** exenatide

**Other Names:**

- Byetta

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1 - exenatide before breakfast and dinner

**Description:** subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)

**Name:** exenatide

**Other Names:**

- Byetta

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12

**Measure:** Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

**Time Frame:** Baseline, Week 12

#### Secondary Outcomes

**Description:** Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

**Measure:** Change in body weight from Baseline to Week 12, and if measured, at each visit

**Time Frame:** Baseline, Weeks 4, 8, 12

**Description:** Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

**Measure:** Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit

**Time Frame:** Baseline, Weeks 4, 8, 12

**Description:** Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

**Measure:** Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12

**Time Frame:** Baseline, Weeks 4, 8, 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD.
* HbA1c between 7.1% and 10.0%, inclusive.
* Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2

Exclusion Criteria:

* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
* Have characteristics contraindicating metformin, SU, or TZD use.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
* Have used any prescription drug to promote weight loss within 3 months prior to screening.
* Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Campinas

**Country:** Brazil

**Facility:** Research Site

**Location 2:**

**City:** Curitiba

**Country:** Brazil

**Facility:** Research Site

**Location 3:**

**City:** Fortaleza

**Country:** Brazil

**Facility:** Research Site

**Location 4:**

**City:** Goiania

**Country:** Brazil

**Facility:** Research Site

**Location 5:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Research Site

**Location 6:**

**City:** Rio de Janeiro

**Country:** Brazil

**Facility:** Research Site

**Location 7:**

**City:** Salvador

**Country:** Brazil

**Facility:** Research Site

**Location 8:**

**City:** Sao Jose Do Rio Preto

**Country:** Brazil

**Facility:** Research Site

**Location 9:**

**City:** Sao Paulo

**Country:** Brazil

**Facility:** Research Site

**Location 10:**

**City:** Guadalajara

**Country:** Mexico

**Facility:** Research Site

**State:** Jalisco

**Location 11:**

**City:** Monterrey

**Country:** Mexico

**Facility:** Research Site

**State:** Nuevo Leon

**Location 12:**

**City:** Merida

**Country:** Mexico

**Facility:** Research Site

**State:** Yucatan

**Location 13:**

**City:** Aguascalientes

**Country:** Mexico

**Facility:** Research Site

**Location 14:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Research Site

**Location 15:**

**City:** San Luis Potosi

**Country:** Mexico

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** Eli Lilly and Company

**Name:** James Malone, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.

**PMID:** 18662495

## 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

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 Diabetes

- 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: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000019440

- Term: Anti-Obesity Agents

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnObAg

- Name: Anti-Obesity Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1726

- Name: Exenatide

- Relevance: HIGH

- As Found: 4 hours

- ID: M29005

- Name: Islet Amyloid Polypeptide

- Relevance: LOW

- As Found: Unknown

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M21396

- Name: Anti-Obesity Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077270

- Term: Exenatide

### Misc Info Module

- Version Holder: 2024-05-24
