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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-04

Study Completion Date

2015-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin 50 mg

Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

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

Glibenclamide 2.50 mg TDD

Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.

Group Type ACTIVE_COMPARATOR

Glibenclamide

Intervention Type DRUG

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

Interventions

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Sitagliptin

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

Intervention Type DRUG

Glibenclamide

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

Intervention Type DRUG

Other Intervention Names

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MK-0431

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No