CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Sitagliptin +1 moredrug
Likely dose
Sitagliptin 50 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/NCT02318693
NCT02318693Phase 4Completed
CompareCT.gov

A Randomized, Open-label, Comparative Clinical Trial to Study the Efficacy of Sitagliptin and Glibenclamide in a Short Term Treatment on the Daily Glucose Variability Using Continuous Glucose Monitoring (CGM) in Japanese Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC·interventional·Posted Dec 17, 2014·Updated Aug 21, 2018

In Brief

A Phase 4 clinical trial evaluating Sitagliptin and Glibenclamide for Type 2 Diabetes Mellitus. Completed, enrolled 53 participants.

Detailed Summary

This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 17, 2014
Enrollment StartFeb 4, 2015
Primary CompletionDec 15, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.5 years ago

Interventions

Sitagliptindrug

Sitagliptin 50 mg orally once a day before breakfast for 14 days

Glibenclamidedrug

Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days