PMID- 32330510 OWN - NLM STAT- MEDLINE DCOM- 20200731 LR - 20200731 IS - 1872-8227 (Electronic) IS - 0168-8227 (Linking) VI - 163 DP - 2020 May TI - A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. PG - 108154 LID - S0168-8227(20)30404-6 [pii] LID - 10.1016/j.diabres.2020.108154 [doi] AB - AIMS: To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. METHODS: DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting >/=1 symptomatic HE. Changes in HbA(1c), fasting plasma glucose (FPG), and body weight were secondary endpoints. RESULTS: The proportion of patients reporting >/=1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA(1c) (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m(2)) between V0 and V1 (p < 0.001). CONCLUSIONS: Patients with T2DM treated with gliclazide MR during Ramadan have a low risk of hypoglycaemia and maintain glycaemic control and weight while fasting. CI - Copyright (c) 2020 The Author(s). Published by Elsevier B.V. All rights reserved. FAU - Hassanein, Mohamed AU - Hassanein M AD - Department of Endocrinology, Dubai Hospital, Dubai, United Arab Emirates. Electronic address: mhassanein148@hotmail.com. FAU - Al Sifri, Saud AU - Al Sifri S AD - Al Hada Military Hospital, Taif, Saudi Arabia. FAU - Shaikh, Shehla AU - Shaikh S AD - Department of Endocrinology, Saifee Hospital, Mumbai, Maharashtra, India. FAU - Abbas Raza, Syed AU - Abbas Raza S AD - Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan. FAU - Akram, Javed AU - Akram J AD - University of Health Sciences, Lahore, Pakistan. FAU - Pranoto, Agung AU - Pranoto A AD - Department of Internal Medicine, Faculty of Medicine, Airlangga University/Dr. Soetomo Hospital, Surabaya, Indonesia. FAU - Rudijanto, Achmad AU - Rudijanto A AD - Department of Internal Medicine, Faculty of Medicine, Brawijaya University/Dr. Saiful Anwar Hospital, Malang, Indonesia. FAU - Shaltout, Inass AU - Shaltout I AD - Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt. FAU - Fariduddin, Md AU - Fariduddin M AD - Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. FAU - Mohd Izani Wan Mohamed, Wan AU - Mohd Izani Wan Mohamed W AD - Department of Medicine, Hospital Universiti Sains Malaysia, Kelantan, Malaysia. FAU - Al Awadi, Fatheya AU - Al Awadi F AD - Department of Endocrinology, Dubai Hospital, Dubai, United Arab Emirates. FAU - Alessa, Thamer AU - Alessa T AD - Dasman Diabetes Institute, Kuwait City, Kuwait. CN - DIA-RAMADAN study investigators LA - eng PT - Journal Article DEP - 20200421 PL - Ireland TA - Diabetes Res Clin Pract JT - Diabetes research and clinical practice JID - 8508335 RN - 0 (Hypoglycemic Agents) RN - G4PX8C4HKV (Gliclazide) SB - IM MH - Aged MH - Diabetes Mellitus, Type 2/*blood MH - Fasting/*blood MH - Female MH - Gliclazide/pharmacology/*therapeutic use MH - Humans MH - Hypoglycemic Agents/pharmacology/*therapeutic use MH - Islam MH - Male MH - Middle Aged MH - Prospective Studies OTO - NOTNLM OT - Diabetes mellitus OT - Diamicron OT - Fasting OT - Gliclazide OT - Ramadan OT - Type 2 COIS- Declaration of competing interests Achmad Rudijanto has received research grants from Novo Nordisk, Sanofi-Aventis, and Servier; Advisory board fees from Sanofi-Aventis, Astra Zeneca, Novo Nordisk, Ely Lilly, and Novartis. Mohamed Hassanein has attended advisory boards or received speaker honoraria from Servier, MSD, Novartis, Novo Nordisk, Sanofi-Aventis, Astra Zeneca and Eli Lilly. Syed Abbas Raza has participated in advisory boards for Sanofi-Aventis, Novo Nordisk, Servier and Ely Lilly. Thamer Alessa has received research grants from Servier; Advisory Board fees from Sanofi-Aventis, Astra Zeneca, Novo Nordisk, Ely Lilly, and Novartis; Honoraria from Sanofi-Aventis, Astra Zeneca, Servier, Novo Nordisk, Ely Lilly, and Novartis. Wan Mohd Izani Wan Mohamed has received research grants Sanofi Aventis, Novartis, GSK, Novo Nordisk, Lilly, Servier, Astra Zeneca, BI, Takeda, MSD, Bayer, and J&J; Speaker honoraria from Novo Nordisk, Lilly, GSK, Sanofi, Novartis, MSD, Astra Zeneca, Servier, Merck, BioRad and Chemopharm. Shehla Shaikh has received advisory board fees and speaker honoraria from Novo Nordisk, Eli Lilly, Novartis, Sanofi-Aventis, MSD and Servier. Inass Shaltout has been a speaker and advisor to Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier, Takeda and Hekma. Agung Pranoto has received research grants from Novo Nordisk and Servier; Advisory Board fees from Sanofi-Aventis, Astra Zeneca, Boehringer Ingelheim, Novo Nordisk, Ely Lilly, and Novartis. Fatheya Al Awadi, Javed Akram, Saud Al Sifri and Md Fariduddin declare no conflicts of interest. EDAT- 2020/04/25 06:00 MHDA- 2020/08/01 06:00 CRDT- 2020/04/25 06:00 PHST- 2020/02/03 00:00 [received] PHST- 2020/04/09 00:00 [revised] PHST- 2020/04/10 00:00 [accepted] PHST- 2020/04/25 06:00 [pubmed] PHST- 2020/08/01 06:00 [medline] PHST- 2020/04/25 06:00 [entrez] AID - S0168-8227(20)30404-6 [pii] AID - 10.1016/j.diabres.2020.108154 [doi] PST - ppublish SO - Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.