Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials

Diabetes, Obesity & Metabolism
R R HenryM Herz

Abstract

To evaluate the potential efficacy, safety and tolerability of aleglitazar as monotherapy or add-on therapy to metformin or to a sulphonylurea (either alone or in combination with metformin). We conducted a pooled analysis of data from three randomized phase III clinical trials of aleglitazar in patients with type 2 diabetes (n = 591). The three studies focused on: (i) aleglitazar alone; (ii) aleglitazar and metformin; and (iii) aleglitazar and sulphonylurea with or without metformin. Patients were randomized to 26 weeks' treatment with aleglitazar 150 µg/day or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline to week 26. Secondary endpoints included changes in lipids, fasting plasma glucose and homeostatic model assessment of insulin resistance (HOMA-IR) at week 26. Reductions in HbA1c concentration from baseline to week 26 were statistically significantly greater with aleglitazar than with placebo. Aleglitazar treatment was associated with more beneficial changes in lipid profiles and HOMA-IR values than was placebo. Aleglitazar was generally well tolerated, with no reports of congestive heart failure. The incidence of peripheral oedema was similar in both groups. Change in ...Continue Reading

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Citations

May 18, 2016·Current Heart Failure Reports·Ersilia M DeFilippis, Michael M Givertz
Apr 4, 2017·Expert Opinion on Investigational Drugs·Gerald H Tomkin, Daphne Owens
Oct 17, 2019·International Journal of Molecular Sciences·Hong Sheng ChengNguan Soon Tan
Nov 3, 2016·Current Opinion in Lipidology·Steven E Gryn, Robert A Hegele
Aug 14, 2020·International Journal of Molecular Sciences·Nicole Wagner, Kay-Dietrich Wagner

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