Vol 10, No 6 (2021)
Research paper
Published online: 2021-05-31

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Real-world evidence on the effectiveness and safety of gliclazide extended-release treatment in Indian patients with type 2 diabetes undergoing Ramadan fast: an analysis from the global DIA-RAMADAN study

Shehla Shaikh1, Sunil Dhand2, Supratik Bhattacharyya3, K. Modi4, S. Moazam5, Sharat S Kolke6, Yogesh Kadam7, Syed Nazim Ahmad8, T. Sivagnanam9, Kunal Kundan10
Clin Diabetol 2021;10(6):438-446.


Background. Glycaemic imbalance, especially hypoglycaemia,

is one of the greatest risks for patients

with type 2 diabetes mellitus (T2DM) during Ramadan

fasting. This paper outlines the efficacy and safety of

gliclazide extended-release (XR) in Indian patients with

T2DM enrolled in the global DIA-RAMADAN study.

Methods. Adults (aged ≥ 18 years) with T2DM who

chose to fast during Ramadan and received a gliclazidebased

regimen once daily for 90 days before Ramadan

were included in the study. Baseline and end-of-study

visits were conducted 6–8 weeks before and 4–6 weeks

after Ramadan, respectively. The primary outcome

was the incidence of ≥ 1 symptomatic hypoglycaemic

event (HE). Changes in glycated haemoglobin (HbA1c),

fasting plasma glucose (FPG), and body weight were

secondary outcomes.

Results. Among 246 Indian patients enrolled in the

study, most (78.9%, n = 194) were at moderate/low

risk as per the International Diabetes Federation and

Diabetes and Ramadan guidelines. Most patients

(69.1%) received gliclazide XR as monotherapy, and

the rest received gliclazide XR with metformin or other

antidiabetic therapy. Significant reductions in HbA1c

(−0.5 ± 0.8%, P < 0.001) and FPG (−21.8 ± 59.4 mg/dL,

P < 0.001) levels were observed but the slight reduction

in body weight was not statistically significant

(−0.3 ± 3.7 kg, P = 0.614) in patients post-Ramadan.

Overall, no HE was reported in Indian patients with

T2DM during Ramadan fasting.

Conclusion. Overall, the effectiveness and safety of

gliclazide XR in Indian patients were consistent with

that observed in the global cohort. Gliclazide XR significantly

reduced HbA1c with no incidence of hypoglycaemic

events in Indian patients with type 2 diabetes

undergoing Ramadan fast, suggesting that gliclazide

XR may be used without dose modification at Iftar to

maintain optimal glycaemic control during Ramadan.

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  1. Federation ID. IDF Diabetes Atlas Eighth Edition. International Diabetes Federation Brussels, Belgium; 2019.
  2. Saboo B, Joshi S, Shah SN, et al. Management of Diabetes during Fasting and Feasting in India. J Assoc Physicians India. 2019; 67: 70–77.
  3. Hassanein M, Al-Arouj M, Hamdy O, et al. International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical guidelines. Diabetes Res Clin Pract. 2017; 126: 303–316.
  4. Ibrahim S, Benard E, Detournay B, et al. A Population-Based Study of Diabetes and Its Characteristics During the Fasting Month of Ramadan in 13 Countries. Diabetes Care. 2004; 27(10): 2306–2311.
  5. Jabbar A, Hassanein M, Beshyah SA, et al. CREED study: Hypoglycaemia during Ramadan in individuals with Type 2 diabetes mellitus from three continents. Diabetes Res Clin Pract. 2017; 132: 19–26.
  6. 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): 819–828.
  7. Ahmad J, Pathan MdF, Jaleel MA, et al. Diabetic emergencies including hypoglycemia during Ramadan. Indian J Endocrinol Metab. 2012; 16(4): 512–515.
  8. Al Sifri S, Basiounny A, Echtay A, et al. 2010 Ramadan Study Group. 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(11): 1132–1140.
  9. Sadikot S, Jothydev K, Zargar AH, et al. Clinical practice points for diabetes management during RAMADAN fast. Diabetes Metab Syndr. 2017; 11 Suppl 2: S811–S819.
  10. Khunti K, Hassanein M, Lee MK, et al. Role of Gliclazide MR in the Management of Type 2 Diabetes: Report of a Symposium on Real-World Evidence and New Perspectives. Diabetes Ther. 2020; 11(Suppl 2): 33–48.
  11. Kalra S, Aamir AH, Raza A, et al. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement. Indian J Endocrinol Metab. 2015; 19(5): 577–596.
  12. World Health O. Guidelines on second- and third-line medicines and type of insulin for the control of blood glucose levels in non-pregnant adults with diabetes mellitus. Geneva: World Health Organization; 2018.
  13. Aravind SR, Al Tayeb K, Ismail SB, et al. 2009 Ramadan Study Group. Hypoglycaemia in sulphonylurea-treated subjects with type 2 diabetes undergoing Ramadan fasting: a five-country observational study. Curr Med Res Opin. 2011; 27(6): 1237–1242.
  14. Aravind SR, Ismail SB, Balamurugan R, 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(8): 1289–1296.
  15. 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: 319–326.
  16. Joshi SR. Glycemic Variability and Ambulatory Glucose Profile in Indian Diabetics. J Assoc Physicians India. 2016; 64(4): 11–14.
  17. Hassanein M, Al Sifri S, Shaikh S, et al. DIA-RAMADAN study investigators. 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.
  18. Brady EM, Davies MJ, Gray LJ, et al. A randomized controlled trial comparing the GLP-1 receptor agonist liraglutide to a sulphonylurea as add on to metformin in patients with established type 2 diabetes during Ramadan: the Treat 4 Ramadan Trial. Diabetes Obes Metab. 2014; 16(6): 527–536.
  19. Zargar AH, Siraj M, Jawa AA, et al. 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(8): 1090–1094.
  20. Sari R, Balci MK, Akbas SH, et al. The effects of diet, sulfonylurea, and Repaglinide therapy on clinical and metabolic parameters in type 2 diabetic patients during Ramadan. Endocr Res. 2004; 30(2): 169–177.
  21. Shete A, Shaikh A, Nayeem KJ, et al. Vildagliptin vs sulfonylurea in Indian Muslim diabetes patients fasting during Ramadan. World J Diabetes. 2013; 4(6): 358–364.
  22. Mbanya JC, Al-Sifri S, Abdel-Rahim A, et al. Incidence of hypoglycemia in patients with type 2 diabetes treated with gliclazide versus DPP-4 inhibitors during Ramadan: A meta-analytical approach. Diabetes Res Clin Pract. 2015; 109(2): 226–232.
  23. Rashid F, Abdelgadir E. A systematic review on efficacy and safety of the current hypoglycemic agents in patients with diabetes during Ramadan fasting. Diabetes Metab Syndr. 2019; 13(2): 1413–1429.
  24. Colagiuri S, Matthews D, Leiter LA, et al. The place of gliclazide MR in the evolving type 2 diabetes landscape: A comparison with other sulfonylureas and newer oral antihyperglycemic agents. Diabetes Res Clin Pract. 2018; 143: 1–14.
  25. Seino S, Takahashi H, Takahashi T, et al. Treating diabetes today: a matter of selectivity of sulphonylureas. Diabetes Obes Metab. 2012; 14 Suppl 1: 9–13.
  26. 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).