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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Actos; Drug: aleglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461006

BC20653

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

Aleglitazar

Experimental group

Treatment:

Drug: aleglitazar

Actos

Active Comparator group

Treatment:

Drug: Actos