IngentaConnect Gliclazide modified release : results of a 2-year study in patien...

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: 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

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$49.48 plus tax Refund Policy

Gliclazide modified release : results of a 2-year study in patients with type 2 diabetes