Trial Information

Summary: A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

Status: No longer recruiting

Protocol Number: BC20653

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double blind study to compare the effects of Aleglitazar and Actos on glomerular filtration rate and other parameters of renal function in patients with Type 2 diabetes.

Brief Summary: This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 176.

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. Relative change from baseline in glomerular filtration rate Time frame: 26 weeks

Key Secondary Outcomes: 1. Relative change from baseline in ERPF and UACR Time frame: 26 weeks 2. Absolute change in HbAlc, FPG and FPI. Time frame: End of treatment 3. 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

Anticipated Start Date: June, 2007

Trial Registration Date: 04/17/2007

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:37:49 PM