A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
- Registration Number
- NCT00461006
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
- adult patients, 18-75 years of age;
- type 2 diabetes for >=1 month;
- drug naive, or receiving stable oral antihyperglycemic medication;
- HbA1c 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;
- Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Actos Actos - Aleglitazar aleglitazar -
- Primary Outcome Measures
Name Time Method Relative change from baseline in glomerular filtration rate 26 weeks
- Secondary Outcome Measures
Name Time Method Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) 26 weeks Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). End of treatment Adverse events (AEs), laboratory parameters. Throughout study