Cargando…

Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN

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,...

Descripción completa

Detalles Bibliográficos
Autores principales: Hassanein, Mohamed, Al Sifri, Saud, Shaikh, Shehla, Raza, Syed Abbas, Akram, Javed, Rudijanto, Achmad, Shaltout, Inass, Fariduddin, Md., Mohamed, Wan Mohd Izani Bin Wan, Al Awadi, Fatheya, Durocher, Alexandra, Cortese, Viviana, Alessa, Thamer
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8179867/
https://www.ncbi.nlm.nih.gov/pubmed/33974216
http://dx.doi.org/10.1007/s13300-021-01067-1
_version_ 1783703879793246208
author Hassanein, Mohamed
Al Sifri, Saud
Shaikh, Shehla
Raza, Syed Abbas
Akram, Javed
Rudijanto, Achmad
Shaltout, Inass
Fariduddin, Md.
Mohamed, Wan Mohd Izani Bin Wan
Al Awadi, Fatheya
Durocher, Alexandra
Cortese, Viviana
Alessa, Thamer
author_facet Hassanein, Mohamed
Al Sifri, Saud
Shaikh, Shehla
Raza, Syed Abbas
Akram, Javed
Rudijanto, Achmad
Shaltout, Inass
Fariduddin, Md.
Mohamed, Wan Mohd Izani Bin Wan
Al Awadi, Fatheya
Durocher, Alexandra
Cortese, Viviana
Alessa, Thamer
author_sort Hassanein, Mohamed
collection PubMed
description 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 HbA(1c) 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: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-021-01067-1.
format Online
Article
Text
id pubmed-8179867
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-81798672021-06-07 Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN Hassanein, Mohamed Al Sifri, Saud Shaikh, Shehla Raza, Syed Abbas Akram, Javed Rudijanto, Achmad Shaltout, Inass Fariduddin, Md. Mohamed, Wan Mohd Izani Bin Wan Al Awadi, Fatheya Durocher, Alexandra Cortese, Viviana Alessa, Thamer Diabetes Ther Original Research 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 HbA(1c) 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: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-021-01067-1. Springer Healthcare 2021-05-11 2021-06 /pmc/articles/PMC8179867/ /pubmed/33974216 http://dx.doi.org/10.1007/s13300-021-01067-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Hassanein, Mohamed
Al Sifri, Saud
Shaikh, Shehla
Raza, Syed Abbas
Akram, Javed
Rudijanto, Achmad
Shaltout, Inass
Fariduddin, Md.
Mohamed, Wan Mohd Izani Bin Wan
Al Awadi, Fatheya
Durocher, Alexandra
Cortese, Viviana
Alessa, Thamer
Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title_full Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title_fullStr Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title_full_unstemmed Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title_short Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN
title_sort descriptive regional subanalysis of a real-world study in patients with type 2 diabetes treated with gliclazide mr during fasting: dia-ramadan
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8179867/
https://www.ncbi.nlm.nih.gov/pubmed/33974216
http://dx.doi.org/10.1007/s13300-021-01067-1
work_keys_str_mv AT hassaneinmohamed descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT alsifrisaud descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT shaikhshehla descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT razasyedabbas descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT akramjaved descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT rudijantoachmad descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT shaltoutinass descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT fariduddinmd descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT mohamedwanmohdizanibinwan descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT alawadifatheya descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT durocheralexandra descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT corteseviviana descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan
AT alessathamer descriptiveregionalsubanalysisofarealworldstudyinpatientswithtype2diabetestreatedwithgliclazidemrduringfastingdiaramadan