Trial Information

Summary: A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

Status: Completed

Protocol Number: BM18249

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized double-blind study to determine the effect of GK Activator (2) on efficacy (HbA1c), safety, tolerability and pharmacokinetics in patients with type 2 diabetes mellitus treated with a stable dose of metformin.

Brief Summary: This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals. Target sample size is 210.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. HbA1c mean change from baseline compared with placebo. Time frame: Week 12

Key Secondary Outcomes: 1. Additional parameters of glycemic and lipid control. Time frame: Week 12 2. AEs, laboratory parameters. Time frame: Throughout study 3. Pharmacokinetic and exposure-response relationship Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 30 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 12/12/2005

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:13:17 PM