Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN.
Diabetes mellitus
Fasting
Gliclazide
Ramadan
Type 2
Journal
Diabetes therapy : research, treatment and education of diabetes and related disorders
ISSN: 1869-6953
Titre abrégé: Diabetes Ther
Pays: United States
ID NLM: 101539025
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
08
04
2021
accepted:
21
04
2021
pubmed:
12
5
2021
medline:
12
5
2021
entrez:
11
5
2021
Statut:
ppublish
Résumé
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. 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. 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 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. Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.
Identifiants
pubmed: 33974216
doi: 10.1007/s13300-021-01067-1
pii: 10.1007/s13300-021-01067-1
pmc: PMC8179867
doi:
Banques de données
ClinicalTrials.gov
['NCT04132934']
Types de publication
Journal Article
Langues
eng
Pagination
1703-1719Références
International Diabetes Federation. IDF diabetes atlas—9th edition. Brussels: International Diabetes Federation; 2019.
Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient’s perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017;5:e000365.
doi: 10.1136/bmjdrc-2016-000365
Al-Arouj M, Assaad-Khalil S, Buse J, Fahdil I, Fahmy M, Hafez S, et al. Recommendations for management of diabetes during Ramadan: update 2010. Diabetes Care. 2010;33:1895–902.
doi: 10.2337/dc10-0896
Hassanein M, Al-Arouj M, Hamdy O, Bebakar WMW, Jabbar A, Al-Madani A, et al. Diabetes and Ramadan: practical guidelines. Diabetes Res Clin Pract. 2017;126:303–16.
doi: 10.1016/j.diabres.2017.03.003
Salti I, Benard E, Detournay B, Bianchi-Biscay M, Le Brigand C, Voinet C, et al. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004;27:2306–11.
doi: 10.2337/diacare.27.10.2306
Sola D, Rossi L, Schianca GP, Maffioli P, Bigliocca M, Mella R, et al. Sulfonylureas and their use in clinical practice. Arch Med Sci. 2015;11:840–8.
doi: 10.5114/aoms.2015.53304
Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, et al. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011;65:1132–40.
doi: 10.1111/j.1742-1241.2011.02797.x
Al-Arouj M, Hassoun AA, Medlej R, Pathan MF, Shaltout I, Chawla MS, et al. The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study. Int J Clin Pract. 2013;67:957–63.
doi: 10.1111/ijcp.12243
Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, et al. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012;28:1289–96.
doi: 10.1185/03007995.2012.707119
Aravind SR, Al Tayeb K, Ismail SB, Shehadeh N, Kaddaha G, Liu R, et al. Hypoglycaemia in sulphonylurea-treated subjects with type 2 diabetes undergoing Ramadan fasting: a five-country observational study. Curr Med Res Opin. 2011;27:1237–42.
doi: 10.1185/03007995.2011.578245
Avogaro A. Treating diabetes today with gliclazide MR: a matter of numbers. Diabetes Obes Metab. 2012;14(Suppl 1):14–9.
doi: 10.1111/j.1463-1326.2011.01508.x
Schernthaner G, Grimaldi A, Di Mario U, Drzewoski J, Kempler P, Kvapil M, et al. GUIDE study: Double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest. 2004;34:535–42.
doi: 10.1111/j.1365-2362.2004.01381.x
International Diabetes Federation and Diabetes and Ramadan. IDF-DAR practical guidelines. Brussels: International Diabetes Federation and Diabetes and Ramadan; 2021.
Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, 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.
doi: 10.1016/j.diabres.2020.108154
Laborotoires Servier. Diamicron 80 mg tablets—summary of product characteristics. Suresnes: Laborotoires Servier; 2020.
American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019;42:S13–28.
doi: 10.2337/dc19-S002
Kilpi F, Webber L, Musaigner A, Aitsi-Selmi A, Marsh T, Rtveladze K, et al. Alarming predictions for obesity and non-communicable diseases in the Middle East. Public Health Nutr. 2014;17:1078–86.
doi: 10.1017/S1368980013000840
Alnohair S. Obesity in gulf countries. Int J Health Sci (Qassim). 2014;8:79–83.
doi: 10.12816/0006074
Abdul-Razak S, Daher AM, Ramli AS, Ariffin F, Mazapuspavina MY, Ambigga KS, et al. Prevalence, awareness, treatment, control and socio demographic determinants of hypertension in Malaysian adults. BMC Public Health. 2016;16:351.
doi: 10.1186/s12889-016-3008-y
Turana Y, Tengkawan J, Soenarta AA. Asian management of hypertension: Current status, home blood pressure, and specific concerns in Indonesia. J Clin Hypertens (Greenwich). 2020;22:483–5.
doi: 10.1111/jch.13681
Lin C-F, Chang Y-H, Chien S-C, Lin Y-H, Yeh H-Y. Epidemiology of dyslipidemia in the Asia Pacific Region. Int J Gerontol. 2018;12:2–6.
doi: 10.1016/j.ijge.2018.02.010
Al-Maatouq M, Al-Arouj M, Assaad SH, Assaad SN, Azar ST, Hassoun AA, et al. Optimising the medical management of hyperglycaemia in type 2 diabetes in the Middle East: pivotal role of metformin. Int J Clin Pract. 2010;64:149–59.
doi: 10.1111/j.1742-1241.2009.02235.x
Hassanein M, Echtay A, Hassoun A, Alarouj M, Afandi B, Poladian R, et al. Tolerability of canagliflozin in patients with type 2 diabetes mellitus fasting during Ramadan: results of the Canagliflozin in Ramadan Tolerance Observational Study (CRATOS). Int J Clin Pract. 2017;71:e12991.
doi: 10.1111/ijcp.12991
Tahapary DL, Astrella C, Kristanti M, Harbuwono DS, Soewondo P. The impact of Ramadan fasting on metabolic profile among type 2 diabetes mellitus patients: a meta-analysis. Diabetes Metab Syndr. 2020;14:1559–70.
doi: 10.1016/j.dsx.2020.07.033
Khaled BM, Belbraouet S. Effect of Ramadan fasting on anthropometric parameters and food consumption in 276 type 2 diabetic obese women. Int J Diabetes Dev Ctries. 2009;29:62–8.
doi: 10.4103/0973-3930.53122
Sfar H, Sellami S, Boukhayatia F, Naceur K, Mami F. Biochemical, physiological and body composition changes in patients with type 2 diabetes during Ramadan fasting. Ibnosina J Med Biomed Sci. 2017;9:164–8.
doi: 10.4103/ijmbs.ijmbs_59_17
Gustaviani R, Soewondo P, Semiardji G, Sudoyo AW. The influence of calorie restriction during the Ramadan fast on serum fructosamine and the formation of beta hydroxybutirate in type 2 diabetes mellitus patients. Acta Med Indones. 2004;36:136–41.
pubmed: 15557682
Yeoh EC, Zainudin SB, Loh WN, Chua CL, Fun S, Subramaniam T, et al. Fasting during Ramadan and associated changes in glycaemia, caloric intake and body composition with gender differences in Singapore. Ann Acad Med Singap. 2015;44:202–6.
pubmed: 26292948
Shadman Z, Poorsoltan N, Akhoundan M, Larijani B, Soleymanzadeh M, Akhgar Zhand C, et al. Ramadan major dietary patterns. Iran Red Crescent Med J. 2014;16:e16801.
pubmed: 25593728
pmcid: 4270674
Zargar AH, Siraj M, Jawa AA, Hasan M, Mahtab H. Maintenance of glycaemic control with the evening administration of a long acting sulphonylurea in male type 2 diabetic patients undertaking the Ramadan fast. Int J Clin Pract. 2010;64:1090–4.
doi: 10.1111/j.1742-1241.2009.02262.x
Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014;10:319–26.
pubmed: 24920915
pmcid: 4045264
Gad H, Hayat T, Al-Muhannadi H, Malik BR, Mussleman P, Malik RA. Efficacy and safety of the newer oral hypoglycemic agents in patients with T2DM during Ramadan: a systematic review and meta-analysis. Diabetes Res Clin Pract. 2021;172:108562.
doi: 10.1016/j.diabres.2020.108562