Phase 4
Completed N=53
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
Source: ClinicalTrials.gov NCT02318693 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 — -18.5; -9.7 mg/dL — p=0.245
◆ Published Evidence
Emerging
11citations · ~1 / year
Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naïve Japanese patients with type 2 diabetes mellitus.
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.
Linked Publications
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Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naïve Japanese patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13 |
-18.5; -9.7 | 0.245 |
| SECONDARY Change From Baseline in the Standard Deviation of Blood Glucose Levels |
-10.2; -4.2 | 0.029 sig |
| SECONDARY Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal |
-24.8; -12.0; -13.2; 1.2; -9.0; -14.1 | 0.041 sig |
| SECONDARY Change From Baseline in 24-hour Mean Glucose Level |
-19.1; -34.8 | 0.020 sig |
| SECONDARY Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL) |
-0.3; 0.8; -0.4; 0.2; -0.3; -0.3 | 0.134 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02318693) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.