Trial Information

Summary: A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Status: Completed

Protocol Number: BC20688

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A double blind, placebo-controlled, dose-ranging study to investigate the effect on glycemic control, safety, pharmacokinetics and pharmacodynamics of GLP-1 in patients with type 2 diabetes mellitus treated with a stable dose of metformin.

Brief Summary: This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 264.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GLP-1

Primary Outcome: 1. Absolute change from baseline in HbAlc Time frame: Week 8

Key Secondary Outcomes: 1. Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. Time frame: Week 8 2. Changes in lipid profile Time frame: Week 8 3. AEs, laboratory parameters, primary pharmacokinetic parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 01/17/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:42:26 PM