open access

Vol 10, No 6 (2021)
Research paper
Submitted: 2021-02-16
Accepted: 2021-03-14
Published online: 2021-05-31
Get Citation

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
DOI: 10.5603/DK.a2021.0041
·
Clinical Diabetology 2021;10(6):438-446.
Affiliations
  1. Saifee Hospital, Mumbai, Mumbai, India
  2. Dhand Diabetes Clinic, Jaipur, India
  3. Apollo Clinic, Kolkata, India
  4. Dr. Modi’s Clinic, Hyderabad, India
  5. Sunshine Hospital, Hyderabad, India
  6. Dr. Kolke's Clinic, Mumbai, India
  7. Poona diabetes Centre, Pune, India
  8. District Hospital, Allahabad, India
  9. Kovai Medical Center and Hospital, Coimbatore, India
  10. Janki Diabetes Care Centre, Patna, India

open access

Vol 10, No 6 (2021)
Original articles
Submitted: 2021-02-16
Accepted: 2021-03-14
Published online: 2021-05-31

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.

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.

Get Citation

Keywords

gliclazide, glycated haemoglobin, hypoglycaemia, 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

Vol 10, No 6 (2021)

Article type

Research paper

Pages

438-446

Published online

2021-05-31

Page views

1794

Article views/downloads

116

DOI

10.5603/DK.a2021.0041

Bibliographic record

Clinical Diabetology 2021;10(6):438-446.

Keywords

gliclazide
glycated haemoglobin
hypoglycaemia
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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