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

Completed · Phase 2

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00461006

Run by

Hoffmann-La Roche

People needed

176

Starts

2007-06-01

Expected to finish

2008-09-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — Los Gatos, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Omaha, Nebraska, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Marion, Ohio, United States
• Study site — Altoona, Pennsylvania, United States
• Study site — Arlington, Texas, United States
• Study site — Arlington, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Midland, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Chihuahua City, Mexico
• Study site — Chihuahua City, Mexico
• Study site — Hermosillo, Mexico
• Study site — Metepec, Mexico
• Study site — Mexico City, Mexico
• Study site — Mexico City, Mexico
• Study site — Mexico City, Mexico
• Study site — Monterrey, Mexico
• Study site — Zapopan, Mexico
• Study site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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