Abstract
INTRODUCTION: This Delphi study aims to provide evidence-based expert opinion on the usage and current position of gliclazide in type 2 diabetes mellitus (T2DM) management in India. METHODS: The single interaction modified Delphi-based methodology was used to collect opinions on gliclazide usage and its position in diabetes management from 338 endocrinologists/diabetologists who have had clinical experience with gliclazide. Participants, using a 9-point scale, were asked to rate eight statements comprising a total of 52 items on the related topics. RESULTS: The Delphi consensus suggests that in drug-naïve patients with T2DM, intolerant to metformin or in whom metformin is contraindicated, dual therapy of gliclazide/gliclazide-modified release (MR) should be considered along with a dipeptidyl peptidase 4 (DPP4) inhibitor if glycated hemoglobin A1c level is greater than 7.5% and with insulin if the A1c level is greater than 9%. If the patients are inadequately controlled with metformin (A1c greater than 6.5% after 3 months of therapy), gliclazide/gliclazide-MR shall be added on to the treatment regimen to achieve greater and sustained reductions in A1c levels. However, it was not preferred over other antidiabetic classes in such clinical settings except alpha-glucosidase inhibitors (AGI). Early addition of gliclazide/gliclazide-MR shall be preferred over the up-titration of metformin beyond half-maximal dose for effective management of T2DM. Gliclazide/gliclazide-MR can be used safely in patients with diabetes and cardiovascular and chronic kidney disease. It can be used in older patients with T2DM as it does not have active metabolites and has a low risk of hypoglycemia. CONCLUSION: The expert panel proposed consideration of monotherapy or dual therapy of gliclazide as an ideal choice in patients with T2DM because of its efficacy, long-term glycemic control, favorable renal outcomes, cardiovascular safety, and an optimal safety profile.