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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.
Details
| Lead sponsor | The Catholic University of Korea |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 165 |
| Start date | 2012-04 |
| Completion | 2014-09 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Acarbose
- Placebo acarbose
- placebo metformin
Primary outcomes
- The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment — baseline, 16 weeks
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
Countries
South Korea