Gliclazide XR effective and safe in diabetic Indian Patients fasting during Ramadan, shows latest Study

The findings of the study are published in the journal Clinical Diabetology.

"The safety and effectiveness of gliclazide XR in Indian patients were consistent with that observed in the global cohort," wrote the authors.

Ramadan is a period of religious fasting observed by Muslims. As the intake of oral antidiabetic drugs is forbidden during daylight in Ramadan, optimal glycemic control becomes challenging for T2D patients. In this scenario, the treatment that allows the stabilization of blood glucose levels while carrying a low risk of hypoglycemia during fasting is highly valuable.

The study by Shehla Shaikh, Saifee Hospital, Mumbai, India, and 9 other investigators from different parts of India, outlines the efficacy and safety of gliclazide extended-release in Indian patients with T2DM enrolled in the global DIA-RAMADAN study, which was a prospective, observational, global study funded by Servier that assessed the real-world safety and effectiveness of gliclazide XR 60 mg in T2D patients fasting during Ramadan. It enrolled 1214 patients from 9 countries (Bangladesh, Egypt, India, Indonesia, Kuwait, Malaysia, Pakistan, Saudi Arabia, and UAE). The highest number of participants were from India, which included 246 participants.

The study was done with a background of a molecule, gliclazide, that has been there for a very long time and is also commonly used in patients during Ramadan.

The sub-analysis was conducted keeping in mind the high number of participants from India as well as the importance of Ramadan in the country. Considering this, Dr. Shaikh and colleagues conducted a sub-analysis of the DIA-RAMADAN study to explore the safety and effectiveness of gliclazide XR 60 mg in Indian patients.

The study included 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. The researchers conducted baseline and end-of-study visits 6–8 weeks before and 4–6 weeks after Ramadan, respectively.

Primary outcome was the incidence of ≥1 symptomatic hypoglycemic event (HE). Changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight were secondary outcomes.

• Among 246 Indian patients enrolled in the study, most (78.9%) 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, with a slight reduction in body weight which was not statistically significant (−0.3±3.7 kg, P = 0.614) in patients post-Ramadan.

• No HE was reported in Indian patients with T2DM during Ramadan fasting.