Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): A phase II, randomised, dose-ranging study
Henry RR et al. – Short-term clinical data show a favorable safety and efficacy profile for the dual peroxisome proliferator-activated receptor (PPAR)-alpha and PPAR-gamma agonist aleglitazar. Methods- SYNCHRONY study: double-blind study to establish glucose-lowering and lipid-modifying effects and safety profile of aleglitazar
- Enrollment of type 2 diabetes pts (either drug-naive or pre-treated with ≤2 oral agents) from 47 sites in 7 countries
- Single-blind, placebo run-in period of 4-5 wks
- Randomization of 332 pts double-blind to 16 wk-treatment with aleglitazar at once-daily doses of 50, 150, 300, or 600, or matching placebo (55 pts in each group), or to open-label pioglitazone 45 mg once daily (57 pts) as a reference
- Primary efficacy endpoint: change in glycosylated hemoglobin (HbA1c) concentration from baseline to treatment end
- Efficacy analysis of pts who received ≥1 dose of study drug and had ≥1 evaluable post-baseline HbA1c measurement
Results- Aleglitazar significantly reduced baseline HbA1c vs placebo in a dose-dependent manner
- Trend of changes over time suggests that maximum effect of aleglitazar on HbA1c concentration not yet reached after 16 wks of treatment
- Edema, hemodilution, and weight gain occurred in a dose-dependent manner
- At aleglitazar doses <300 microg, no pts had congestive heart failure, similar frequency to placebo for edema and less than with pioglitazone, and bodyweight gain was less than with pioglitazone
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