Authors: Drouin, P.¹; Standl, E.²

Source: Diabetes, Obesity and Metabolism, Volume 6, Number 6, November 2004 , pp. 414-421(8)

Publisher: Wiley-Blackwell

Abstract:

Aim: 

To evaluate the efficacy and safety of gliclazide modified release (MR), alone or combined with other oral antidiabetic drug(s) over 2 years in type 2 diabetic patients. Methods: 

Two consecutive periods: (i) a 10-month, double-blind comparative study, where 800 type 2 diabetic patients were randomized either to gliclazide MR (30-120 mg) once daily or to gliclazide (80-320 mg) twice daily. All the patients were then treated with gliclazide MR for a 2-month switch period; (ii) 549 patients were subsequently enrolled in a 12-month, open-label period on gliclazide MR alone or in combination according to glycaemic control, 507 of whom completed the study. Results: 

Glycated haemoglobin (HbA1c) significantly decreased from baseline over 2 years by −0.46 ± 1.08% in the whole cohort of 2-year completed patients, −0.95% in the subgroup of diet-failed patients and by −0.34% in the subgroup of patients pretreated with one oral antidiabetic drug. HbA1c was reduced by −0.43 ± 1.02% and by −0.51 ± 1.16%, when gliclazide MR was used in monotherapy and in combination therapy, respectively. The overall incidence of symptoms suggestive of hypoglycaemia was 4.8 episodes/100 patient-year, with no severe episode. This incidence was similarly low in elderly patients and patients with impaired renal function. Conclusion: 

Gliclazide MR alone or in combination with another oral antidiabetic drug significantly improved glycaemic control in type 2 diabetic patients over 2 years with a very good safety profile, notably in the elderly and in patients with impaired renal function.

Keywords: elderly; gliclazide modified release; impaired renal function; long-term efficacy; type 2 diabetes

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1462-8902.2004.00404.x

Affiliations: 1: Centre Hospitalo-Universitaire de Nancy, Hôpital Jeanne d'Arc, BP 303, 54201 Toul Cedex, France 2: Akademisches Krankenhaus München-Schwabing, Medizinische Abteilung und Institut für Diabetes Forschung, Munchen, Germany

Publication date: 2004-11-01

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