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 LevelChange 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
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