A Phase 2 interventional study of Actos and aleglitazar in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 52 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-01.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 176 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Exclusion Criteria:
Drug: aleglitazar
Drug: Actos
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
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aleglitazar