Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study
Aim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & met...
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| Format: | Article |
| Language: | English |
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Becaris Publishing Limited
2024-01-01
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| Series: | Journal of Comparative Effectiveness Research |
| Subjects: |
| _version_ | 1797323957299314688 |
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| author | Mohammed Farid Uddin Murshed Ahamed Khan Shahjada Selim Nusrat Sultana Mohammad Abu Sayem Mohammed Mahboob Iftekhar Maruf Bin Habib Nazma Akter Shahjamal Khan |
| author_facet | Mohammed Farid Uddin Murshed Ahamed Khan Shahjada Selim Nusrat Sultana Mohammad Abu Sayem Mohammed Mahboob Iftekhar Maruf Bin Habib Nazma Akter Shahjamal Khan |
| author_sort | Mohammed Farid Uddin |
| collection | DOAJ |
| description | Aim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased
risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness
and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & methods:
DIA-RAMADAN was an international, prospective, observational study conducted in adult T2DM patients
intending to fast and receiving gliclazide MR 60 mg once daily for ≥90 days before Ramadan. Dosing was
switched from morning to evening at the start of Ramadan. The primary outcome was the proportion
of patients with ≥1 symptomatic hypoglycemic event. Secondary outcomes included changes between
inclusion (V0) and end of study visit (V1) in glycated hemoglobin (HbA1c), body weight and fasting
plasma glucose (FPG). Results: Among the 98 Bangladeshi patients, 80 (81.6%) were at moderate/low risk
(category 3) for fasting and 18 (18.4%) were high-risk (category 2), as per International Diabetes
Federation and Diabetes and Ramadan International Alliance (IDF-DAR) guidelines. Gliclazide MR was
being prescribed as monotherapy to 59 (60.2%) patients and in combination with metformin to 39
(39.8%). There was no incidence of severe hypoglycemic events. Mean (±SD) HbA1c change from V0 was -
0.1 ± 0.8% (p = 0.159).Mean (±SD) changes in FPG and body weight were -0.8 ± 39.7mg/dl (p = 0.876) and
-0.0 ± 1.5 kg (p = 0.810), respectively. Conclusion: In a real-world setting, this sub-analysis in Bangladeshi
patients shows that patients with T2DM treated with gliclazide MR 60 mg can fast safely during Ramadan
with a very low risk of hypoglycemia, while maintaining glycemic control and body weight. |
| first_indexed | 2024-03-08T05:36:30Z |
| format | Article |
| id | doaj.art-0881fecd1baa4089931521b31c291709 |
| institution | Directory Open Access Journal |
| issn | 2042-6313 |
| language | English |
| last_indexed | 2024-03-08T05:36:30Z |
| publishDate | 2024-01-01 |
| publisher | Becaris Publishing Limited |
| record_format | Article |
| series | Journal of Comparative Effectiveness Research |
| spelling | doaj.art-0881fecd1baa4089931521b31c2917092024-02-05T16:15:47ZengBecaris Publishing LimitedJournal of Comparative Effectiveness Research2042-63132024-01-0113210.57264/cer-2023-0132Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN studyMohammed Farid Uddin0https://orcid.org/0000-0002-7537-0933Murshed Ahamed Khan1https://orcid.org/0000-0002-2863-3876Shahjada Selim2https://orcid.org/0000-0001-7749-3542Nusrat Sultana3https://orcid.org/0000-0002-6858-2110Mohammad Abu Sayem4Mohammed Mahboob Iftekhar5Maruf Bin Habib6Nazma Akter7https://orcid.org/0000-0003-0830-0748Shahjamal Khan8Department of Endocrinology and Metabolism, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka, 1000, BangladeshDepartment of Endocrinology and Metabolism, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka, 1000, BangladeshDepartment of Endocrinology and Metabolism, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka, 1000, BangladeshDepartment of Endocrinology and Metabolism, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka, 1000, BangladeshPopular Diagnostic Centre Ltd. Dhanmondi, Dhaka, 1205, BangladeshDepartment of Diabetes and Endocrinology, BIRDEM General Hospital, Dhaka, 1000, BangladeshDepartment of Medicine, Uttara Adhunik Medical College & Hospital, Dhaka, 1230, BangladeshDepartment of Endocrinology and Metabolism, MARKS Medical College & Hospital, Dhaka, 1206, BangladeshDepartment of Endocrinology, Enam Medical College & Hospital, Dhaka, 1340, BangladeshAim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & methods: DIA-RAMADAN was an international, prospective, observational study conducted in adult T2DM patients intending to fast and receiving gliclazide MR 60 mg once daily for ≥90 days before Ramadan. Dosing was switched from morning to evening at the start of Ramadan. The primary outcome was the proportion of patients with ≥1 symptomatic hypoglycemic event. Secondary outcomes included changes between inclusion (V0) and end of study visit (V1) in glycated hemoglobin (HbA1c), body weight and fasting plasma glucose (FPG). Results: Among the 98 Bangladeshi patients, 80 (81.6%) were at moderate/low risk (category 3) for fasting and 18 (18.4%) were high-risk (category 2), as per International Diabetes Federation and Diabetes and Ramadan International Alliance (IDF-DAR) guidelines. Gliclazide MR was being prescribed as monotherapy to 59 (60.2%) patients and in combination with metformin to 39 (39.8%). There was no incidence of severe hypoglycemic events. Mean (±SD) HbA1c change from V0 was - 0.1 ± 0.8% (p = 0.159).Mean (±SD) changes in FPG and body weight were -0.8 ± 39.7mg/dl (p = 0.876) and -0.0 ± 1.5 kg (p = 0.810), respectively. Conclusion: In a real-world setting, this sub-analysis in Bangladeshi patients shows that patients with T2DM treated with gliclazide MR 60 mg can fast safely during Ramadan with a very low risk of hypoglycemia, while maintaining glycemic control and body weight.diabetesfastinggliclazide modified releasehypoglycemiaramadan |
| spellingShingle | Mohammed Farid Uddin Murshed Ahamed Khan Shahjada Selim Nusrat Sultana Mohammad Abu Sayem Mohammed Mahboob Iftekhar Maruf Bin Habib Nazma Akter Shahjamal Khan Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study Journal of Comparative Effectiveness Research diabetes fasting gliclazide modified release hypoglycemia ramadan |
| title | Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study |
| title_full | Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study |
| title_fullStr | Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study |
| title_full_unstemmed | Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study |
| title_short | Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study |
| title_sort | real world evidence on the effectiveness and safety of gliclazide mr 60 mg in bangladeshi patients with type ii diabetes during fasting a sub analysis from the global dia ramadan study |
| topic | diabetes fasting gliclazide modified release hypoglycemia ramadan |
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