Vol 10, No 6 (2021)
Research paper
Published online: 2021-05-31

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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

Shehla Shaikh1, Sunil Dhand2, Supratik Bhattacharyya3, K. Modi4, S. Moazam5, Sharat S Kolke6, Yogesh Kadam7, Syed Nazim Ahmad8, T. Sivagnanam9, Kunal Kundan10
Clin Diabetol 2021;10(6):438-446.

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 gliclazidebased

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.

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