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
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.
Keywords: gliclazideglycated haemoglobinhypoglycaemiaRamadantype 2 diabetes mellitus
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