CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,147 enrolled
Drug / intervention
Sitagliptin phosphate +2 moredrug
Likely dose
Sitagliptin phosphate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01131182
NCT01131182Phase 4Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted May 26, 2010·Updated Sep 21, 2022

In Brief

A Phase 4 clinical trial evaluating Sitagliptin phosphate, Comparator: Sulfonylurea, and 1 other intervention for Type 2 Diabetes Mellitus (T2DM). Completed, enrolled 1,147 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus (T2DM)
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartJun 13, 2010
Primary CompletionNov 4, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.1 years ago

Interventions

Sitagliptin phosphatedrug

Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.

Comparator: Sulfonylureadrug

Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription

Metformindrug

Participants could continue pre-study metformin as concomitant therapy during the study.