DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Sitagliptin (Drug); Glibenclamide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merck Sharp & Dohme Corp.

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13

Secondary outcome:

Change from Baseline in 24-hour Mean Glucose Level

Change from Baseline in the Standard Deviation of Blood Glucose Levels

Change from Baseline in Incremental Postprandial Glucose Levels in Each Meal

Change in Baseline in Percentage of Hypoglycemic Values (glucose sensor readings: < 70, <60, <50 mg/dL)

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Japanese participants with a diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

- History of Type 1 diabetes mellitus or ketoacidosis

- History of insulin or thiazolidinedione (including fixed-dose drug combinations

containing one of these drugs) in the 12 weeks before study participation

Locations and Contacts

Toll Free Number, Phone: 1-888-577-8839

MSD K.K., Chiyoda-Ku, Tokyo 102-8667, Japan; Recruiting
Japan Call Center, Phone: 81-3-6272-1957
Additional Information

Starting date: February 2015
Last updated: August 13, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017