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Diabetes and Vascular Disease Research
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The effects of tesaglitazar as add-on treatment to metformin in patients with poorly controlled type 2 diabetes

Burkhard Göke

Department of Internal Medicine II, University of Munich - Grosshadern, Marchinioninstr. 15, 81377 Munich, Germany.

Ingrid Gause-Nilsson

AstraZeneca R&D Mölndal, SE-431 83, Mölndal, Sweden.

Anders Persson

AstraZeneca R&D Mölndal, SE-431 83, Mölndal, Sweden.

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 crea-tinine 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.

Key Words: dyslipidaemia • peroxisome proliferator-activated receptor • metformin • tesaglitazar • type 2 diabetes mellitus

Diabetes and Vascular Disease Research, Vol. 4, No. 3, 204-213 (2007)
DOI: 10.3132/dvdr.2007.041
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