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Exp Clin Endocrinol Diabetes 2003; 111(5): 262-266
DOI: 10.1055/s-2003-41752
Article

J. A. Barth Verlag in Georg Thieme Verlag Stuttgart · New York

Efficacy, Tolerability and Safety of Nateglinide in Combination with Metformin. Results from a Study under General Practice Conditions

H. Schatz 1 , K. Schoppel 2 , D. Lehwalder 3 , R. Schandry 4
  • 1Medizinische Universitätsklinik Bergmannsheil, Ruhr-Universität Bochum, Bochum, Germany
  • 2Novartis Pharma GmbH, Nürnberg, Germany
  • 3Merck KgaA, Darmstadt, Germany
  • 4Department Psychologie, Biologische Psychologie, Ludwig-Maximilians-Universität München, Munich, Germany
Further Information

Publication History

Received: September 29, 2002 First decision: December 4, 2002

Accepted: March 13, 2003

Publication Date:
02 September 2003 (online)

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Abstract

In a general practice observation study 11 476 patients with type 2 diabetes pretreated with oral antidiabetic drugs, mainly metformin, received an oral combination therapy of nateglinide with metformin. Mean age ± SD of the participants was 61 ± 10.3 years, range 19 to 97 years, the body mass index (mean ± SD) was 29.4 ± 4.5 kg/m2, range 14.9 to 68.7 kg/m2. The observation period lasted 3 to 4 months (mean 96 days). During this period the mean HbA1c decreased from 8.4 % to 7.2 %, displaying a positive relation between initial value and degree of reduction. Postprandial glucose levels dropped from a mean of 210 to 152 mg/dl. At the beginning of the study the combination of the two target values for glucose control, HbAc < 7 % and postprandial glucose < 180 mg/dl, was reached in only 5.8 % of the participants, at the end in 44.9 %. During the therapy, weight and blood pressure dropped slightly. Adverse events were reported in only 2.9 % of the patients and involved a broad range of symptoms with mild gastrointestinal complaints being predominant (1.3 %). This study demonstrated that the combination of nateglinide with metformin can be considered as an effective and safe option for treatment of patients with type 2 diabetes, with additional beneficial effects on body weight and blood pressure.

Key words

Nateglinide - metformin - general practice study - safety - tolerability

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Univ.-Prof. Dr. Helmut Schatz

Berufsgenossenschaftliche Kliniken Bergmannsheil
Universitätsklinik, Medizinische Klinik und Poliklinik

Bürkle-de-la-Camp-Platz 1

44789 Bochum

Germany

Phone: + 492343026400

Fax: + 49 23 43 02 64 03

Email: helmut.schatz@ruhr-uni-bochum.de

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