drugset / Trial / NCT01340768

Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

NCT01340768

Phase 3 Completed 870 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Timeline

Start
2010-06-22
Primary completion
2011-09-21
Completion
2011-09-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gliclazide Small molecule
Comparator Glimepiride Small molecule
Comparator Glyburide Small molecule
Subject Sitagliptin Small molecule 100 mg Oral
Background Metformin Small molecule