A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
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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.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
type 1 diabetes;
current or previous treatment with insulin;
history of renal disease other than diabetic nephropathy;
clinically significant cardiovascular disease;
Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.