A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/3/2016 |
| Start Date: | June 2007 |
| End Date: | April 2009 |
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.
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.
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.
We found this trial at
16
sites
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