Evaluation of the effectiveness and tolerability of gliclazide modified release 60 mg in patients with type 2 diabetes observing fasting during Ramadan in Pakistan: An analysis from the global DIA-RAMADAN study
Year: 2021
Type: article
Abstract: Aim To assess safety and effectiveness of gliclazide MR 60 mg in people with controlled or suboptimal controlled T2DM treated with breakable gliclazide MR 60 mg formulation. Method This study data has been extracted from an international, observational study conducted in nine Asian and Middle Eastern countries. Total 220 patients with T2DM were recruited from Pakistan. The primary endpoint was the proportion of patients reporting at least 1 symptomatic HE, whereas secondary endpoints were changes in glycosylated haemoglobin (HbA 1c ) %, fasting plasma glucose (FPG) mg/dL, and body weight (kg) and proportion of patients reporting any HE (confirmed or severe), between inclusion visit (V0) and end of the study visit (V1). Results During Ramadan, 3.6% (n = 8/220) patients had experienced at least one symptomatic HEs. A significant (p-value < 0.001) reduction was observed in HbA 1c : (mean [SD]) (−0.4 [0.9] %), and body weight (−0.7 [4.8] kg). Thirteen adverse events (AEs) unrelated to gliclazide MR were reported during the study pre-Ramadan and post-Ramadan periods. Conclusion This study shows safety and effectiveness profile of gliclazide MR 60 mg by emphasizing on the low risk of HEs, effective glycaemic control and body weight reduction in T2DM patients, who are inclined to fasting during Ramadan.
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,400
OpenAlex ID: W3205496527