Official 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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: aleglitazar
  • 0.6mg po daily
• Drug: Actos
  • 45mg po daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Relative change from baseline in glomerular filtration rate
  • Time Frame: 26 weeks
    Safety Issue?: No

Secondary Measures

• Relative change from baseline in ERPF and UACR
  • Time Frame: 26 weeks
    Safety Issue?: No
• Absolute change in HbAlc, FPG and FPI.
  • Time Frame: End of treatment
    Safety Issue?: No
• AEs, laboratory parameters.
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• adult patients, 18-75 years of age;
• type 2 diabetes for >=1 month;
• drug naive, or receiving stable oral antihyperglycemic medication;
• HbAlc 6.5-10.0% at screening.

Exclusion Criteria:

• type 1 diabetes;
• current or previous treatment with insulin;
• history of renal disease other than diabetic nephropathy;
• uncontrolled hypertension;
• clinically significant cardiovascular disease;
• CHF NYHA 3-4.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461006

Study ID Number: BC20653

ClinicalTrials.gov Identifier: NCT00461006

Health Authority: United States: Food and Drug Administration