NCT01131182

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

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,147 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Sitagliptin phosphate	Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
DRUG	Comparator: Sulfonylurea	Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
DRUG	Metformin	Participants could continue pre-study metformin as concomitant therapy during the study.

Timeline

• Start date: 2010-06-13
• Primary completion: 2010-11-04
• Completion: 2010-11-04
• First posted: 2010-05-26
• Last updated: 2022-09-21
• Results posted: 2012-01-20