Trial Information

Summary: A Study of Aleglitazar in Patients With Type 2 Diabetes

Status: Completed

Protocol Number: BM17864

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to investigate the effect of aleglitazar on glycemic control in patients with Type 2 diabetes mellitus.

Brief Summary: This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.

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: aleglitazar

Primary Outcome: 1. Absolute change from baseline in HbAlc Time frame: 16 weeks

Key Secondary Outcomes: 1. Absolute change from baseline in FPG, HbAlc response rate, insulin sensitivity, beta cell function and cardiovascular markers. Time frame: 16 weeks 2. AEs, laboratory 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: 10/17/2006

Date Last Updated: 10/28/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:36:13 PM