Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Summary

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Timeline

Start

2010-06-13

Primary completion

2010-11-04

Completion

2010-11-04

Outcome

Met primary endpoint

registry analysis (unspecified test); Sitagliptin vs Sulfonylurea; p = 0.0005; Cochran-Mantel-Haenszel; NCT01131182 ↗

paper The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment PMID 21951832 ↗

Publications

• Results Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 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 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27.
• Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Gliclazide	Small molecule	—	Oral
Comparator	Glimepiride	Small molecule	—	Oral
Comparator	Glyburide	Small molecule	—	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	—	—

Indications