## Protocol Section
### Identification Module
**NCT ID:** NCT00366379

**Brief Title:** A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

**Official Title:** An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.

#### Organization Study ID Info
**ID:** BC19800
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
### Status Module
#### Completion Date
**Date:** 2007-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-06

**Type:** ACTUAL

#### Start Date
**Date:** 2006-07

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2006-08-21
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-16
**Study First Submit QC Date:** 2006-08-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

### Conditions Module

**Conditions:**

- Diabetes Mellitus Type 2

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 127

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: GK Activator (2)

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: GK Activator (2)

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: GK Activator (2)

**Label:** 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: GK Activator (2)

**Label:** 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Intervention Names:**

- Drug: GK Activator (2)

**Label:** 5

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

- 3

- 4

- 5

**Description:** 25-200mg po bid for 20 weeks

**Name:** GK Activator (2)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of patients at each dose who achieve FPG <100mg/dL.

**Time Frame:** Throughout study

#### Secondary Outcomes

**Measure:** Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.

**Time Frame:** At intervals throughout study

**Measure:** AEs, laboratory parameters.

**Time Frame:** Throughout study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chandler

**Country:** United States

**State:** Arizona

**Zip:** 85225

**Location 2:**

**City:** Oviedo

**Country:** United States

**State:** Florida

**Zip:** 32765

**Location 3:**

**City:** Nampa

**Country:** United States

**State:** Idaho

**Zip:** 83687

**Location 4:**

**City:** Evansville

**Country:** United States

**State:** Indiana

**Zip:** 47714

**Location 5:**

**City:** Butte

**Country:** United States

**State:** Montana

**Zip:** 59701

**Location 6:**

**City:** Canton

**Country:** United States

**State:** Ohio

**Zip:** 44718

**Location 7:**

**City:** Portland

**Country:** United States

**State:** Oregon

**Zip:** 97239

**Location 8:**

**City:** Greer

**Country:** United States

**State:** South Carolina

**Zip:** 29651

**Location 9:**

**City:** Midland

**Country:** United States

**State:** Texas

**Zip:** 79707

**Location 10:**

**City:** Richmond

**Country:** United States

**State:** Virginia

**Zip:** 23249

**Location 11:**

**City:** Tallinn

**Country:** Estonia

**Zip:** 10138

**Location 12:**

**City:** Tartu

**Country:** Estonia

**Zip:** 50406

**Location 13:**

**City:** Tartu

**Country:** Estonia

**Zip:** 50708

**Location 14:**

**City:** Tartu

**Country:** Estonia

**Zip:** 51014

**Location 15:**

**City:** Jelgava

**Country:** Latvia

**Zip:** 3001

**Location 16:**

**City:** Riga

**Country:** Latvia

**Zip:** 1002

**Location 17:**

**City:** Riga

**Country:** Latvia

**Zip:** 1038

**Location 18:**

**City:** Chihuahua

**Country:** Mexico

**Zip:** 31238

**Location 19:**

**City:** Guadalajara

**Country:** Mexico

**Zip:** 44340

**Location 20:**

**City:** Guadalajara

**Country:** Mexico

**Zip:** 44650

**Location 21:**

**City:** Pachuca

**Country:** Mexico

**Zip:** 42086

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

## 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: 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 - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
