CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 870 enrolled
Drug / intervention
Sitagliptin +2 moredrug
Likely dose
Sitagliptin 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/NCT01340768
NCT01340768Phase 3Completed
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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 Apr 25, 2011·Updated Jun 5, 2017

In Brief

A Phase 3 clinical trial evaluating Sitagliptin, Sulfonylurea, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 870 participants.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2011
Enrollment StartJun 22, 2010
Primary CompletionSep 21, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.2 years ago

Interventions

Sitagliptindrug

One 100 mg tablet taken orally once daily

Sulfonylureadrug

Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.

Metformindrug

Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.