drugset / Trial / NCT02318693

Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)

NCT02318693

Phase 4 Completed 53 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-02-04
Primary completion
2015-12-15
Completion
2015-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glyburide Small molecule 1.25 mg Oral
Subject Sitagliptin Small molecule 50 mg Oral