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© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study.

Methods

DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6–8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4–6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.

Results

Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.

Conclusion

These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.

Trial Registration

Clinicaltrials.gov identifier NCT04132934.

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Details

Title
Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
Author
Hassanein, Mohamed 1 ; Al Sifri, Saud 2 ; Shaikh, Shehla 3 ; Raza, Syed Abbas 4 ; Akram, Javed 5 ; Rudijanto, Achmad 6 ; Shaltout, Inass 7 ; Fariduddin, Md. 8 ; Mohamed, Wan Mohd Izani Bin Wan 9 ; Al Awadi, Fatheya 1 ; Durocher, Alexandra 10 ; Cortese, Viviana 10 ; Alessa, Thamer 11 

 Dubai Hospital, Department of Endocrinology, Dubai, United Arab Emirates (GRID:grid.414162.4) (ISNI:0000 0004 1796 7314) 
 Al Hada Military Hospital, Taif, Saudi Arabia (GRID:grid.414162.4) 
 Saifee Hospital, Department of Endocrinology, Mumbai, India (GRID:grid.416467.6) (ISNI:0000 0004 1807 8279) 
 Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (GRID:grid.415662.2) (ISNI:0000 0004 0607 9952) 
 University of Health Sciences, Lahore, Pakistan (GRID:grid.412956.d) 
 Brawijaya University/Dr., Saiful Anwar Hospital, Department of Internal Medicine, Faculty of Medicine, Malang, Indonesia (GRID:grid.490384.2) 
 Cairo University, Department of Internal Medicine, Faculty of Medicine, Cairo, Egypt (GRID:grid.7776.1) (ISNI:0000 0004 0639 9286) 
 Bangabandhu Sheikh Mujib Medical University, Department of Endocrinology, Dhaka, Bangladesh (GRID:grid.411509.8) (ISNI:0000 0001 2034 9320) 
 Hospital Universiti Sains Malaysia, Department of Medicine, Kota Bharu, Malaysia (GRID:grid.428821.5) (ISNI:0000 0004 1801 9172); Universiti Sains Malaysia (USM) Health Campus, School of Medical Sciences, Kubang Kerian, Malaysia (GRID:grid.11875.3a) (ISNI:0000 0001 2294 3534) 
10  Servier Global Medical and Patient Affairs-Diabetes, Suresnes Cedex, France (GRID:grid.414162.4) 
11  Dasman Diabetes Institute, Kuwait City, Kuwait (GRID:grid.452356.3) (ISNI:0000 0004 0518 1285) 
Pages
1703-1719
Publication year
2021
Publication date
Jun 2021
Publisher
Springer Nature B.V.
ISSN
18696953
e-ISSN
18696961
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2938151697
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.