The effects of tesaglitazar as add-on treatment to metformin in patients with poorly controlled type 2 diabetes.

Author(s): Goke B, Gause-Nilsson I, Persson A, GALLANT 8 Study Group

Affiliation(s): Department of Internal Medicine II, University of Munich-Grosshadern, Marchinioninstr. 15, 81377 Munich, Germany. Burkhard.Goeke@med.uni-muenchen.de

Publication date & source: 2007-09, Diab Vasc Dis Res., 4(3):204-13.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

This study assessed the effects of tesaglitazar (0.5 or 1 mg/day), a dual peroxisome proliferator-activated receptor alpha/gamma agonist, when added to maximally tolerated metformin (2-2.5 g/day) in patients with poorly controlled type 2 diabetes. The primary end point of this 24-week, randomised, placebo-controlled study was the absolute change from baseline in glycosylated haemoglobin (HbA1C). Tesaglitazar significantly reduced HbA1C, fasting plasma glucose and insulin levels compared with placebo (p<0.0001 for all) when added to metformin. Triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-HDL-C levels also improved with tesaglitazar treatment (p<0.0001 for all). Adverse events were generally similar across treatments, except for higher frequencies of peripheral oedema and weight gain in the tesaglitazar 1 mg group. Although reversibility was not fully evaluated, dose-dependent changes in mean serum creatinine levels and haematology measures tended to return towards baseline at follow-up. Despite the clinical discontinuation of tesaglitazar, this study has demonstrated the potential benefits of dual PPAR agonism as add-on therapy to metformin, in patients with poorly controlled type 2 diabetes.