Trial Information

Summary: A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and Class II Heart Failure.

Status: Completed

Protocol Number: BC20265

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double blind study to compare the safety and tolerability of Aleglitazar and Actos in patients with Type 2 diabetes and NYHA class II heart failure.

Brief Summary: This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 200.

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. Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.

Key Secondary Outcomes: 1. Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period., AEs, lab. parameters. Efficacy: Change from baseline to week 26 in HbAlc, FPG, FPI and lipid profile.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 04/17/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 1:51:58 PM