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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 Shaikh, Sunil Dhand, Supratik Bhattacharyya, K. Modi, S. Moazam, Sharat S Kolke, Yogesh Kadam, Syed Nazim Ahmad, T. Sivagnanam, Kunal Kundan
DOI: 10.5603/DK.a2021.0041

open access

Ahead of print
Original articles (submitted)
Published online: 2021-05-31

Abstract

Context and Aim: Glycemic imbalance, especially hypoglycemia, 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 and Material: 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 were included in the study. Baseline and end-of-study visits were conducted 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. 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 was consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycemic 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 glycemic control during Ramadan.

Abstract

Context and Aim: Glycemic imbalance, especially hypoglycemia, 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 and Material: 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 were included in the study. Baseline and end-of-study visits were conducted 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. 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 was consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycemic 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 glycemic control during Ramadan.

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Keywords

Gliclazide; Glycated hemoglobin; Hypoglycemia; Ramadan; Type 2 diabetes mellitus

About this article
Title

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

Journal

Clinical Diabetology

Issue

Ahead of print

Article type

Research paper

Published online

2021-05-31

DOI

10.5603/DK.a2021.0041

Keywords

Gliclazide
Glycated hemoglobin
Hypoglycemia
Ramadan
Type 2 diabetes mellitus

Authors

Shehla Shaikh
Sunil Dhand
Supratik Bhattacharyya
K. Modi
S. Moazam
Sharat S Kolke
Yogesh Kadam
Syed Nazim Ahmad
T. Sivagnanam
Kunal Kundan

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