Login Register Cart 0
Generic placeholder image

Current Diabetes Reviews

Editor-in-Chief

ISSN (Print): 1573-3998
ISSN (Online): 1875-6417

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Real-world Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Mellitus During the Period of Ramadan in Four Countries (Egypt, Jordan, Lebanon, and Turkey): A Prospective Observational Study

Author(s): Mohamed Hassanein*, Inass Shaltout, Rachid Malek, Samir Assaad Khalil, Hajar Ballout, Firas Annabi and Mark Shereen

Volume 20, Issue 5, 2024

Published on: 17 October, 2023

Article ID: e110823219694 Pages: 11

DOI: 10.2174/1573399820666230811152520

Price: $65

Abstract

Aim: This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan.

Background: Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting.

Objective: The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan.

Methods: We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan.

Results: One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9% ±1.4% pre-Ramadan to 6.9% ±0.4% post-Ramadan. The overall HBA1c target value was 6.9% ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3 mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia.

Conclusion: Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications.

[1]
Islam by Country. Available from: https://en.wikipedia.org/wiki/Islam_by_country
[2]
Beshyah SA, Ali KF, Hafidh K, Hajjaji IM. Ramadan fasting and diabetes 2019: The year in review. Diabetes Res Clin Pract 2021; 172: 108593.
[http://dx.doi.org/10.1016/j.diabres.2020.108593] [PMID: 33316310]
[3]
Ahmed SH, Chowdhury TA, Hussain S, et al. Ramadan and diabetes: A narrative review and practice update. Diabetes Ther 2020; 11(11): 2477-520.
[http://dx.doi.org/10.1007/s13300-020-00886-y] [PMID: 32909192]
[4]
Beshyah SA, Chowdhury TA, Ghouri N, Lakhdar AA. Risk of diabetic ketoacidosis during Ramadan fasting: A critical reappraisal. Diabetes Res Clin Pract 2019; 151: 290-8.
[http://dx.doi.org/10.1016/j.diabres.2019.02.027] [PMID: 30836132]
[5]
International Diabetes Federation. Available from: https://idf.org/
[6]
Højlund K, Wildner-Christensen M, Eshøj O, et al. Reference intervals for glucose, β-cell polypeptides, and counterregulatory factors during prolonged fasting. Am J Physiol Endocrinol Metab 2001; 280(1): E50-8.
[http://dx.doi.org/10.1152/ajpendo.2001.280.1.E50]
[7]
Thomas F. Scott The Effect of the Muslim Fast of Ramadan on Routine Laboratory Investigations. J King Abdulaziz Univ - Med Sci 1981; 1.
[8]
Azizi F, Rasouli HA. Serum glucose, bilirubin, calcium, phosphorus, protein and albumin con- centrations during ramadan. Med J Islam Repub Iran 1987; 1: 38-41.
[9]
Bouguerra R, Jabrane J, Maâtki C, et al. Ramadan fasting in type 2 diabetes mellitus. Ann Endocrinol 2006; 67: 54-9.
[http://dx.doi.org/10.1016/S0003-4266(06)72541-0]
[10]
Katibi IA, Akande AA, Bojuwoye BJ, Okesina AB. Blood sugar control among fasting Muslims with type 2 diabetes mellitus in Ilorin. Niger J Med 2001; 10(3): 132-4.
[PMID: 11806014]
[11]
Akanji AO, Mojiminiyi OA, Abdella N. Beneficial changes in serum apo A-1 and its ratio to apo B and HDL in stable hyperlipidaemic subjects after Ramadan fasting in Kuwait. Eur J Clin Nutr 2000; 54(6): 508-13.
[http://dx.doi.org/10.1038/sj.ejcn.1601047] [PMID: 10878654]
[12]
Mafauzy M, Mohammed WB, Anum MY, Zulkifli A. A study of the fasting diabetic patients during the month of ramadan. Med J Malaysia 1990; 45(1): 14-7.
[13]
Ebada MA, Fayed N, Fayed L, et al. Efficacy of alpha-lipoic acid in the management of diabetes mellitus: A systematic review and meta-analysis. Iran J Pharm Res 2019; 18(4): 2144-56.
[http://dx.doi.org/10.22037/ijpr.2019.1100842] [PMID: 32184879]
[14]
Belkhadir J, el Ghomari H, Klöcker N, Mikou A, Nasciri M, Sabri M. Muslims with non-insulin dependent diabetes fasting during Ramadan: Treatment with glibenclamide. BMJ 1993; 307(6899): 292-5.
[http://dx.doi.org/10.1136/bmj.307.6899.292] [PMID: 8374375]
[15]
Abdelhaleem IA, Salamah HM, Alsabbagh FA, et al. Efficacy and safety of imeglimin in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized clinical trials. Diabetes Metab Syndr 2021; 15(6): 102323.
[http://dx.doi.org/10.1016/j.dsx.2021.102323]
[16]
Hassanein M, Al Sifri S, Shaikh S, et al. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract 2020; 163: 108154.
[http://dx.doi.org/10.1016/j.diabres.2020.108154] [PMID: 32330510]
[17]
Al-Arouj M, Assaad-Khalil S, Buse J, et al. Recommendations for management of diabetes during Ramadan: Update 2010. Diabetes Care 2010; 33(8): 1895-902.
[http://dx.doi.org/10.2337/dc10-0896] [PMID: 20668157]
[18]
Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003; 26(11): 3080-6.
[http://dx.doi.org/10.2337/diacare.26.11.3080] [PMID: 14578243]
[19]
Fritsche A, Schweitzer MA, Hring H-U. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. Ann Intern Med 2003; 138(12): 952.
[http://dx.doi.org/10.7326/0003-4819-138-12-200306170-00006]
[20]
Hassanein M, Buyukbese MA, Malek R, et al. Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: The observational ORION study. Diabetes Res Clin Pract 2020; 166: 108189.
[http://dx.doi.org/10.1016/j.diabres.2020.108189] [PMID: 32360709]
[21]
Hassanein M, Al-Arouj M, Hamdy O, et al. Diabetes and ramadan: Practical guidelines. Diabetes Res Clin Pract 2017; 126: 303-16.
[http://dx.doi.org/10.1016/j.diabres.2017.03.003] [PMID: 28347497]
[22]
Cesur M, Corapcioglu D, Gursoy A, et al. A comparison of glycemic effects of glimepiride, repaglinide, and insulin glargine in type 2 diabetes mellitus during Ramadan fasting. Diabetes Res Clin Pract 2007; 75(2): 141-7.
[http://dx.doi.org/10.1016/j.diabres.2006.05.012] [PMID: 16815586]
[23]
Bakiner O, Ertorer ME, Bozkirli E, Tutuncu NB, Demirag NG. Repaglinide plus single-dose insulin glargine: A safe regimen for low-risk type 2 diabetic patients who insist on fasting in Ramadan. Acta Diabetol 2009; 46(1): 63-5.
[http://dx.doi.org/10.1007/s00592-008-0062-7] [PMID: 18825302]
[24]
Babineaux SM, Toaima D, Boye KS, et al. Multi‐country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med 2015; 32(6): 819-28.
[http://dx.doi.org/10.1111/dme.12685] [PMID: 25581456]
[25]
Ba-Essa EM, Hassanein M, Abdulrhman S, Alkhalifa M, Alsafar Z. Attitude and safety of patients with diabetes observing the Ramadan fast. Diabetes Res Clin Pract 2019; 152: 177-82.
[http://dx.doi.org/10.1016/j.diabres.2019.03.031] [PMID: 30946851]
[26]
Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin‐naïve people with type 2 diabetes on oral glucose‐lowering drugs: A randomized controlled trial (Edition 3). Diabetes Obes Metab 2015; 17(4): 386-94.
[http://dx.doi.org/10.1111/dom.12438] [PMID: 25641260]
[27]
Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 Units/ML versus insulin degludec 100 Units/ML in insulin-naive type 2 diabetes: The randomized head-to-head bright trial. Diabetes Care 2018; 41(10): 2147-54.
[http://dx.doi.org/10.2337/dc18-0559]
[28]
Ibrahim M, Davies MJ, Ahmad E, et al. Recommendations for management of diabetes during ramadan: Update 2020, applying the principles of the ADA/EASD consensus. BMJ Open Diabetes Res Care 2020; 8(1): e001248.
[http://dx.doi.org/10.1136/bmjdrc-2020-001248]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy