Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Acarbose Added on Top of Metformin and Sitagliptin Combination Treatment in Type 2 Diabetes Mellitus Patients
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.
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
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