Trial Information

Summary: A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

Status: Recruiting

Protocol Number: BC20750

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and effect of taspoglutide compared to placebo, in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

Brief Summary: This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals. Target sample size is 330.

Study Phase: III

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: taspoglutide

Primary Outcome: 1. Absolute change from baseline in HbA1c Time frame: 24 weeks

Key Secondary Outcomes: 1. Change from baseline in fasting plasma glucose; change from baseline in body weight. Time frame: 24 weeks 2. Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function. Time frame: 24 weeks 3. Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2008

Trial Registration Date: 08/29/2008

Date Last Updated: 10/28/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:55:31 PM