Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Sitagliptin 50 mg administered orally once daily before breakfast for 14 days. arm 2: Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.

Interventions: intervention 1: Sitagliptin intervention 2: Glibenclamide
Intervention descriptions: intervention 1: Sitagliptin 50 mg orally once a day before breakfast for 14 days intervention 2: Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days

Protocol document: