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Diabetes and Vascular Disease Research
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Efficacy, safety and tolerability of tesaglitazar when added to the therapeutic regimen of poorly controlled insulin-treated patients with type 2 diabetes

Robert E Ratner

MedStar Research Institute, Hyattsville, MD, US.

Shamik Parikh

AstraZeneca, 1800 Concord Pike, Wilmington, DE, US.

Conrad Tou

AstraZeneca, 1800 Concord Pike, Wilmington, DE, US.

This randomised, double-blind, parallel-group study assessed the effects of addition of the dual peroxisome proliferator-activated receptor (PPAR) {alpha}/{gamma} agonist, tesaglitazar, for 24 weeks to the therapeutic regimen of 392 poorly controlled (glycosylated haemoglobin [HbA1C] 7.5-10%) insulin-treated, type 2 diabetes patients.

At 24 weeks, tesaglitazar 0.5 mg resulted in a 0.66% (95% confidence intervals: –0.85, –0.47; p<0.0001) reduction from baseline in HbA1C, and reduced fasting plasma glucose (p<0.0001) and daily insulin dose (p=0.014) versus placebo. After 24 weeks, tesaglitazar caused greater improvements from baseline in triglyc-erides (p<0.0001), high-density lipoprotein cholesterol (HDL-C) (p<0.001), non-HDL-C (p<0.05), apolipopro-tein (apo)A-I (p<0.05) and apoB levels (p<0.01) than placebo. Tesaglitazar was generally well tolerated but was associated with a greater increase in serum creatinine level than placebo.

The clinical development of tesaglitazar is no longer continuing; its effects on the glucose and lipid abnormalities of type 2 diabetes suggest that the concept of dual PPAR{alpha}/{gamma} agonism is worthy of further investigation.

Key Words: dual PPAR{alpha}/{gamma} agonist • insulin • tesaglitazar • type 2 diabetes

Diabetes and Vascular Disease Research, Vol. 4, No. 3, 214-221 (2007)
DOI: 10.3132/dvdr.2007.042
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