The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial

Abstract

Summary Aims: To compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan. Methods: Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA1c < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open‐label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end‐point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan. Results: Of the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel–Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan. Conclusions: In Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin‐based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea‐based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.

Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA‐Ramadan): a randomized trial

“…Furthermore, because of the MTD requirement, for patients randomized to sulphonylurea, the pre‐trial sulphonylurea was to be kept stable until Ramadan. The dose of sulphonylureas in this trial was, however, consistent with or higher than doses used in other Ramadan trials, as well as in clinical practice 9, 10, 11, 31, 32, 33, 34. Generally, for sulphonylureas administered at higher than half the maximum approved dose, the glucose‐lowering effect levels off as the dose increases 35.…”

“…Glibenclamide/glyburide may be associated with a higher risk of hypoglycaemia than other second‐generation sulphonylureas, specifically gliclazide, glimepiride and glipizide 29, 30. Gliclazide, previously shown to have a low hypoglycaemia rate during Ramadan, was the most frequently used sulphonylurea in this trial 10. Importantly, however, it seems the lower risk of ADA‐documented symptomatic hypoglycaemic episodes with liraglutide versus sulphonylurea applied to all the second‐generation sulphonylureas used in this trial.…”

“…Incretin‐based therapy may be an alternative to sulphonylureas for T2D management during Ramadan because of the inherent low risk of hypoglycaemia. There have been several observational and interventional trials investigating the efficacy and safety of dipeptidyl peptidase‐4 (DPP‐4) inhibitors when used during Ramadan 9, 10, 11. By contrast, limited clinical data exist on the efficacy and safety of glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) when used during Ramadan.…”

Initial increase in glucose variability during Ramadan fasting in non-insulin-treated patients with diabetes type 2 using continuous glucose monitoring

“…SU has previously been associated with higher risk of hypoglycaemia during Ramadan fasting compared to other oral anti-diabetic drugs in patients with diabetes type 2 [9–15]. It is worth mentioning that no CGM was used in these studies to monitor glycaemic variation and hypoglycaemia.…”

The use of gliclazide in the mirror of the individualized sulfonylurea therapy

“…Az adatok értékelését nehezíti azonban, hogy az ismeretek nagy része experimentális megfi gyelésekből származik, továbbá, hogy pros pektív tanulmányokból származó "kemény végpontú" eredmé-nyek, illetve az egyes származékokat összehasonlító ("head-to-head") vizsgálatok nem, illetve csak korláto-zottan állnak rendelkezésre. Kétségtelen ugyanakkor, hogy egyre bővül a SU-hatás biokémiai hátterével kapcsolatos ismeretek köre [4,5,6], s nő a pancreasszelektívnek tartott származékok (a második generációs vegyü-letek közül a gliclazid) klinikai előnyeiről beszámoló közlemények [7,8,9,10] száma is.…”