Mohamed Hassanein1, Saud Al Sifri2, Shehla Shaikh3, Syed Abbas Raza4, Javed Akram5, Achmad Rudijanto6, Inass Shaltout7, Md Fariduddin8, Wan Mohd Izani Bin Wan Mohamed9,10, Fatheya Al Awadi1, Alexandra Durocher11, Viviana Cortese12, Thamer Alessa13. 1. Department of Endocrinology, Dubai Hospital, Dubai, United Arab Emirates. 2. Al Hada Military Hospital, Taif, Saudi Arabia. 3. Department of Endocrinology, Saifee Hospital, Mumbai, Maharashtra, India. 4. Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan. 5. University of Health Sciences, Lahore, Pakistan. 6. Department of Internal Medicine, Faculty of Medicine, Brawijaya University/Dr., Saiful Anwar Hospital, Malang, Indonesia. 7. Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt. 8. Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. 9. Department of Medicine, Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia. 10. School of Medical Sciences, Universiti Sains Malaysia (USM) Health Campus, Kubang Kerian, Kelantan, Malaysia. 11. Servier Global Medical and Patient Affairs-Diabetes, 35 rue de Verdun, 92284, Suresnes Cedex, France. Alexandra.durocher@servier.com. 12. Servier Global Medical and Patient Affairs-Diabetes, 35 rue de Verdun, 92284, Suresnes Cedex, France. 13. Dasman Diabetes Institute, Kuwait City, Kuwait.
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. INFOGRAPHIC.
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. INFOGRAPHIC.
Entities:
Keywords:
Diabetes mellitus; Fasting; Gliclazide; Ramadan; Type 2
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