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
1 Dubai Hospital, Department of Endocrinology, Dubai, United Arab Emirates (GRID:grid.414162.4) (ISNI:0000 0004 1796 7314)
2 Al Hada Military Hospital, Taif, Saudi Arabia (GRID:grid.414162.4)
3 Saifee Hospital, Department of Endocrinology, Mumbai, India (GRID:grid.416467.6) (ISNI:0000 0004 1807 8279)
4 Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (GRID:grid.415662.2) (ISNI:0000 0004 0607 9952)
5 University of Health Sciences, Lahore, Pakistan (GRID:grid.412956.d)
6 Brawijaya University/Dr., Saiful Anwar Hospital, Department of Internal Medicine, Faculty of Medicine, Malang, Indonesia (GRID:grid.490384.2)
7 Cairo University, Department of Internal Medicine, Faculty of Medicine, Cairo, Egypt (GRID:grid.7776.1) (ISNI:0000 0004 0639 9286)
8 Bangabandhu Sheikh Mujib Medical University, Department of Endocrinology, Dhaka, Bangladesh (GRID:grid.411509.8) (ISNI:0000 0001 2034 9320)
9 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)