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

NCT02318693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-08-21

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin

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

DRUG

Glibenclamide

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318693 on ClinicalTrials.gov