Trial Information

Summary: A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Status: Completed

Protocol Number: NC19794

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A multi-center, open label, extension study to evaluate the long-term safety and tolerability of GK Activator (2) in type 2 diabetic patients from studies BM18248 or BM18249

Brief Summary: This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 259.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• 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. AEs, laboratory parameters, ECG. Time frame: Throughout study

Key Secondary Outcomes: 1. Mean change from original baseline in HbA1c, FPG, lipid profile. 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: 05/04/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:31:56 PM