Gliclazide Modified Release

Publisher Website
Google Scholar
Abstract
▴ Gliclazide modified release (MR) is a new formulation of the drug gliclazide and is given once daily. The hydrophilic matrix ofhypromellose-based polymer in the new formulation effects a progressive release of the drug which parallels the 24-hour glycaemic profile in untreated patients with type 2 diabetes mellitus. ▴ The formulation shows high bioavailability and its absorption profile is unaffected by coadministration with food. Mean plasma glucose levels are significantly reduced over a 24-hour period in patients with type 2 diabetes mellitus treated with gliclazide MR once daily, in both fasting and postprandial states. ▴ No cardiovascular ATP-sensitive potassium channel interaction has been observed at therapeutic concentrations of gliclazide MR. Gliclazide MR has also demonstrated antioxidant properties that are independent of glycaemic control. ▴ In a randomised, double-blind, multicentre study, gliclazide MR 30 to 120mg once daily showed similar efficacy to gliclazide immediate release (IR) 80 to 320 mg/day (in divided doses for doses >80ms) in patients with type 2 diabetes mellitus over a 10-montn period, reducing glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) to a similar extent. ▴ The drug appeared most efficacious in patients who had previously been treated by diet alone, where significant reductions in HbAic from baseline of 0.9% and 0.95% were seen at 10 and 24 months. Similarly, a sustained effect of gliclazide MR was observed in a subgroup of elderly patients defined a priori; HbAic was decreased to a similar degree to that observed in the general study population. ▴ Gliclazide MR showed similar tolerability to gliclazide IR after 10 months’ treatment in the randomised trial. The most commonly observed adverse events were arthralgia, arthritis, back pain and bronchitis (each <5%). Bodyweight remained stable. ▴ In this study no episodes of nocturnal hypoglycaemia or hypoglycaemia requiring third party assistance were observed during treatment with gliclazide MR. Episodes of symptomatic hypoglycaemia were infrequent, occurring in approximately 5% of patients.

This publication has 30 references indexed in Scilit: