Real-world evidence on the effectiveness and safety of gliclazide extended-release treatment in Indian patients with type 2 diabetes undergoing Ramadan fast: an analysis from the global DIA-RAMADAn study

Abstract

background. Glycaemic imbalance, especially hypoglycaemia, is one of the greatest risks for patients with type 2 diabetes mellitus (t2DM) during Ramadan fasting. This paper outlines the efficacy and safety of gliclazide extended-release (XR) in Indian patients with t2DM enrolled in the global DIA-RAMADAn study. Methods. Adults (aged ≥ 18 years) with t2DM who chose to fast during Ramadan and received a gliclazide-based regimen once daily for 90 days before Ramadan were included in the study. baseline and end-of-study visits were conducted 6–8 weeks before and 4–6 weeks after Ramadan, respectively. the primary outcome was the incidence of ≥ 1 symptomatic hypoglycaemic event (HE). Changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight were secondary outcomes. Results. Among 246 Indian patients enrolled in the study, most (78.9%, n = 194) were at moderate/low risk as per the International Diabetes Federation and Diabetes and Ramadan guidelines. Most patients (69.1%) received gliclazide XR as monotherapy, and the rest received gliclazide XR with metformin or other antidiabetic therapy. Significant reductions in HbA1c (−0.5 ± 0.8%, P < 0.001) and FPG (−21.8 ± 59.4 mg/dL, P < 0.001) levels were observed but the slight reduction in body weight was not statistically significant (−0.3 ± 3.7 kg, P = 0.614) in patients post-Ramadan. Overall, no HE was reported in Indian patients with t2DM during Ramadan fasting. Conclusion. Overall, the effectiveness and safety of gliclazide XR in Indian patients were consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycaemic events in Indian patients with type 2 diabetes undergoing Ramadan fast, suggesting that gliclazide XR may be used without dose modification at Iftar to maintain optimal glycaemic control during Ramadan. (Clin Diabetol 2021; 10; 4: 438–446)