Premium
Gliclazide modified release *: results of a 2‐year study in patients with type 2 diabetes
Author(s) -
Drouin P.,
Standl E.
Publication year - 2004
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1462-8902.2004.00404.x
Subject(s) - gliclazide , medicine , type 2 diabetes , incidence (geometry) , diabetes mellitus , subgroup analysis , combination therapy , gastroenterology , cohort , confidence interval , endocrinology , physics , optics
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.