Conditions: Type 2 Diabetes Mellitus
Keywords: Acarbose ACADEMIC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 165
Healthy volunteers: no

Brief summary:
Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy.

The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.

Detailed description:
Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the following groups and primary efficacy variable analyzed at week 16.

group 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo + sitagliptin (with switching placebo to metformin at week 16)

After 16 week of treatment, all subjects in 3 groups will be treated as triple combination of acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed.

1. Primary Endpoint Changes in HbA1c (hemoglobin A1c) at 16 week from baseline between group1 vs grou2
2. Secondary Endpoints (1) Changes of HbA1c at 24 week between 3 groups (2) Changed of post-prandial blood glucose at 2 hour (ppg2h) at 16, 24 week

for exploratory purpose, following data will be collected and analyzed

1. continuous glucose monitoring system (CGMS) data among selected subjects in 3 groups
2. mixed meal tolerance test in only available institution. (glucose, insulin, GLP-1, GIP, glucagon ) among selected subjects in group 1 and group 2
3. oxidative stress markers (8-OHdG, nitrotyrosin, CML)
4. self monitoring of blood glucose

Arms:
arm 1: The Acarbose placebo should be changed into real Acarbose from the 16th week. arm 2: Metformin, Sitagliptin, Acarbose group arm 3: The Metformin placebo should be changed into real Metformin from the 16th week.

Interventions: intervention 1: Acarbose intervention 2: Placebo acarbose intervention 3: placebo metformin
Intervention descriptions: intervention 1: Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid. intervention 2: acarbose placebo intervention 3: metformin placebo

Protocol document: