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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glibenclamide; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318693

0431-355

152867 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Sitagliptin 50 mg

Experimental group

Description:

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

Treatment:

Drug: Sitagliptin

Glibenclamide 2.50 mg TDD

Active Comparator group

Description:

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

Treatment:

Drug: Glibenclamide