| Summary: | Aim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased
risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness
and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & methods:
DIA-RAMADAN was an international, prospective, observational study conducted in adult T2DM patients
intending to fast and receiving gliclazide MR 60 mg once daily for ≥90 days before Ramadan. Dosing was
switched from morning to evening at the start of Ramadan. The primary outcome was the proportion
of patients with ≥1 symptomatic hypoglycemic event. Secondary outcomes included changes between
inclusion (V0) and end of study visit (V1) in glycated hemoglobin (HbA1c), body weight and fasting
plasma glucose (FPG). Results: Among the 98 Bangladeshi patients, 80 (81.6%) were at moderate/low risk
(category 3) for fasting and 18 (18.4%) were high-risk (category 2), as per International Diabetes
Federation and Diabetes and Ramadan International Alliance (IDF-DAR) guidelines. Gliclazide MR was
being prescribed as monotherapy to 59 (60.2%) patients and in combination with metformin to 39
(39.8%). There was no incidence of severe hypoglycemic events. Mean (±SD) HbA1c change from V0 was -
0.1 ± 0.8% (p = 0.159).Mean (±SD) changes in FPG and body weight were -0.8 ± 39.7mg/dl (p = 0.876) and
-0.0 ± 1.5 kg (p = 0.810), respectively. Conclusion: In a real-world setting, this sub-analysis in Bangladeshi
patients shows that patients with T2DM treated with gliclazide MR 60 mg can fast safely during Ramadan
with a very low risk of hypoglycemia, while maintaining glycemic control and body weight.
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