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Horm Metab Res 2002; 34(10): 589-595
DOI: 10.1055/s-2002-35421
Original Clinical
© Georg Thieme Verlag Stuttgart · New York

Metabolic Efficacy and Safety of Once-Daily Pioglitazone Monotherapy in Patients with Type 2 Diabetes: A Double-Blind, Placebo-Controlled Study

W.  A.  Scherbaum 1 , B.  Göke 2 , and the German Pioglitazone Study Group
  • 1German Diabetes Center at the Heinrich-Heine-Universität Düsseldorf, Germany
  • 2Medizinische Klinik und Poliklinik II, Klinikum Großhadern, Ludwig-Maximilian-Universität, Munich, Germany
Further Information

Publication History

Received: 3 January 2002

Accepted after revision: 9 July 2002

Publication Date:
19 November 2002 (online)

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Abstract

Pioglitazone is a novel oral anti-diabetic agent belonging to the thiazolidinedione class. Pioglitazone has been shown to be effective and well tolerated in the treatment of patients with type 2 diabetes, as it reduces insulin resistance and improves glycaemic control and abnormal lipid profiles. This double-blind, randomised, placebo-controlled study was conducted for further evaluation of the efficacy and tolerability of once-daily administration of pioglitazone monotherapy alongside dietary measures in patients with type 2 diabetes. Following a 10-week washout period, 251 patients received one of three treatment regimens for 26 weeks: placebo + diet (n = 84), pioglitazone 15 mg once-daily + diet (n = 89), or pioglitazone 30 mg once-daily + diet (n = 78). Pioglitazone, both 15 and 30 mg/day, in addition to dietary control, was associated with significant reductions (vs. placebo) in mean levels of both glycosylated haemoglobin (HbA1C) and fasting blood glucose (FBG). HbA1C was reduced by 0.92 % and 1.05 %, respectively, and FBG was reduced by 34.3 and 36.0 mg/dl, respectively, compared with the control group. Pioglitazone at 15 and 30 mg/day significantly reduced postprandial blood glucose levels at all visits (- 163 and - 165 mg/dl/hour, respectively) compared with an increase of 47.7 mg/dl/hour on placebo. The profile and frequency of adverse events were similar in all treatment groups. These results indicate that pioglitazone monotherapy together with dietary control is both effective and safe in patients with type 2 diabetes.

Key words

Pioglitazone - Type 2 Diabetes - Insulin Resistance - Glycaemic Control

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W. A. Scherbaum, M.D.

German Diabetes Center at the Heinrich-Heine-Universität Düsseldorf ·

Auf'm Hennekamp 65 · 40225 Düsseldorf · Germany ·

Phone: + 49 (211) 33821

Fax: + 49 (211) 3369103 ·

Email: scherbaum@ddfi.uni-duesseldorf.de