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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
176
45mg po daily
0.6mg po daily
Relative change from baseline in glomerular filtration rate
Time frame: 26 weeks
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Time frame: 26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Time frame: End of treatment
Adverse events (AEs), laboratory parameters.
Time frame: Throughout study
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Peoria, Arizona, United States
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Jonesboro, Arkansas, United States
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Fresno, California, United States
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Los Gatos, California, United States
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Mission Viejo, California, United States
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Jacksonville, Florida, United States
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Omaha, Nebraska, United States
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Charlotte, North Carolina, United States
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Marion, Ohio, United States
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Altoona, Pennsylvania, United States
...and 42 more locations