Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study

Abstract

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 ± 39.7 mg/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.

Plain language summary

What is this article about?

Many Muslims with Type II diabetes choose to observe the religious fast during Ramadan. However, even among those with stable levels of blood glucose, the management of Type II diabetes can be challenging. With only two meals per day and no food during daylight, large swings in blood glucose levels may occur because of the long gap between meals, larger amounts of food consumed and no intake of oral antidiabetes drugs during daylight. This sub-analysis of the international DIA-RAMADAN study examined the real-world safety and effectiveness of gliclazide modified release (MR) 60 mg among fasting patients with Type II diabetes in Bangladesh.

What were the results?

The results showed that Type II diabetes in Bangladeshi patients can be safely managed during Ramadan fasting when intake of the patient's gliclazide MR dose is switched from morning to evening dosing. No severe hypoglycemic events were reported and patients maintained glycemic control with no weight changes.

What do the results of the study mean?

The gliclazide MR formulation results in gradual drug release with a low risk of hypoglycemia and is a safe option for patients who plan to fast during Ramadan.

Tweetable abstract

A recent subanalysis of an international study shows that the sulphonylurea, gliclazide MR 60 mg, is a safe option for patients with Type II diabetes in Bangladesh who plan to fast during Ramadan.