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A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN

Hassanein M 1 , Al Sifri S 2 , Shaikh S 3 , Abbas Raza S 4 , Akram J 5 , Pranoto A 6 Show all authors , Rudijanto A 7 , Shaltout I 8 , Fariduddin M 9 , Mohd Izani Wan Mohamed W 10 , Al Awadi F 11 , Alessa T 12 , DIA-RAMADAN study investigators

Affiliations 

  • 1 Department of Endocrinology, Dubai Hospital, Dubai, United Arab Emirates. Electronic address: [email protected]
  • 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, Airlangga University/Dr. Soetomo Hospital, Surabaya, Indonesia
  • 7 Department of Internal Medicine, Faculty of Medicine, Brawijaya University/Dr. Saiful Anwar Hospital, Malang, Indonesia
  • 8 Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt
  • 9 Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • 10 Department of Medicine, Hospital Universiti Sains Malaysia, Kelantan, Malaysia
  • 11 Department of Endocrinology, Dubai Hospital, Dubai, United Arab Emirates
  • 12 Dasman Diabetes Institute, Kuwait City, Kuwait
Diabetes Res Clin Pract, 2020 May;163:108154.
PMID: 32330510 DOI: 10.1016/j.diabres.2020.108154

Abstract

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 HbA1c, 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 HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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