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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
165
Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.
acarbose placebo
metformin placebo
MedicalExcellence
Seoul, South Korea
The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
Time frame: baseline, 16 weeks
The Change of HbA1c From Baseline to 24 Weeks of Treatment
The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups
Time frame: baseline, 24 weeks
The Change of PPG2hr From Baseline to 24 Weeks of Treatment
The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups
Time frame: baseline, 24 weeks
Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time frame: Visit 2(baseline) and Visit 5(16W)
Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time frame: Visit 2(baseline) and Visit 5(16W)
Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Time frame: baseline, 16 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Time frame: baseline, 16 week
Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time frame: Visit 2(baseline) and Visit 5(16W)