Authors: Charbonnel, B. H.; Matthews, D. R.¹; Schernthaner, G.²; Hanefeld, M.³; Brunetti, P.⁴

Source: Diabetic Medicine, Volume 22, Number 4, April 2005 , pp. 399-405(7)

Publisher: Wiley-Blackwell

Abstract:

Aims 

This study compared the effects of pioglitazone and gliclazide on metabolic control in drug-naïve patients with Type 2 diabetes mellitus. Methods 

A total of 1270 patients with Type 2 diabetes were randomized in a parallel-group, double-dummy, double-blind study. Patients with poorly controlled Type 2 diabetes (HbA_1c 7.5–11%), despite dietary advice, received either pioglitazone up to 45 mg once daily or gliclazide up to 160 mg two times daily. Primary efficacy endpoint was change in HbA_1c from baseline to the end of the study. Secondary efficacy endpoints included change in fasting plasma glucose, fasting plasma insulin and plasma lipids. At selected centres, oral glucose tolerance tests were performed and C-peptide and pro-insulin levels were measured. Results 

Mean HbA_1c values decreased by the same amount in the two treatment groups from baseline to week 52 [pioglitazone: −1.4%; gliclazide: −1.4%; (90% CI: −0.18 to 0.02)]. A significantly greater mean reduction in fasting plasma glucose was observed in the pioglitazone group (2.4 mmol/l) than in the gliclazide group [2.0 mmol/l; treatment difference −0.4 mmol/l in favour of pioglitazone; P = 0.002; (95% CI: −0.7 to −0.1)]. Improvements in high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C were greater with pioglitazone than with gliclazide (P < 0.001). The frequencies of adverse events were comparable between the two treatment groups, but more hypoglycaemic events were reported for gliclazide, whereas twice as many patients reported oedema with pioglitazone than with gliclazide. Conclusions 

Pioglitazone monotherapy was equivalent to gliclazide in reducing HbA_1c, with specific differences between treatments in terms of mechanism of action, plasma lipids and adverse events.

Diabet. Med. (2004)

Keywords: gliclazide; long-term; pioglitazone; thiazolidinedione; Type 2 diabetes mellitus

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1464-5491.2004.01426.x

Affiliations: 1: Oxford Centre for Diabetes, Endocrinology and Metabolism, Radcliffe Infirmary, Oxford, UK, 2: Department of Medicine I, Rudolfstiftung Hospital, Vienna, Austria, 3: Centre for Clinical Studies, GWT, Technical University Dresden, Germany and 4: Internal Medicine and Metabolic Diseases Department Universita di Perugia, Perugia, Italy

Publication date: 2005-04-01

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