A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN.
Diabetes mellitus
Diamicron
Fasting
Gliclazide
Ramadan
Type 2
Journal
Diabetes research and clinical practice
ISSN: 1872-8227
Titre abrégé: Diabetes Res Clin Pract
Pays: Ireland
ID NLM: 8508335
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
03
02
2020
revised:
09
04
2020
accepted:
10
04
2020
pubmed:
25
4
2020
medline:
1
8
2020
entrez:
25
4
2020
Statut:
ppublish
Résumé
To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. 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 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 Patients with T2DM treated with gliclazide MR during Ramadan have a low risk of hypoglycaemia and maintain glycaemic control and weight while fasting.
Identifiants
pubmed: 32330510
pii: S0168-8227(20)30404-6
doi: 10.1016/j.diabres.2020.108154
pii:
doi:
Substances chimiques
Hypoglycemic Agents
0
Gliclazide
G4PX8C4HKV
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
108154Informations de copyright
Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
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.