Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Acarbose; Placebo acarbose; placebo metformin
Intervention description: 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
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Acarbose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: placebo medication
Enrollment: 165.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acarbose; ACADEMIC

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with type-II diabetes mellitus;

          2. Subjects aged between 20 and 80;

          3. Subjects whose HbA1c ratio is between 7.0% and 10.0%;

          4. Subjects who took Metformin and Sitagliptin for at least 12 weeks;

          5. Subjects who were given the explanation about this clinical study and signed the
             consent form.

        Exclusion Criteria:

          1. Subjects who have taken drugs that are likely to affect blood glucose or who need to
             take such drugs, e.g., glucocorticoid;

          2. Subjects with severe renal diseases (men: Scr>1.5 / women: Scr>1.4);

          3. Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher
             than the upper limits of normal (ULN);

          4. Subjects having the case history of lactic acidosis;

          5. Subjects who have the case history of myocardial infarction or unstable angina or who
             underwent the coronary artery bypass graft 6 months before the screening test or who
             have arrhythmia to be treated;

          6. Subjects with congestive heart failures to be treated;

          7. Subjects who fall into New York Heart Association (NYHA) class III or IV;

          8. Subjects having the case history of acute or chronic metabolic acidosis including
             ketoacidosis;

          9. Subjects who have been pregnant or who are in the period of lactation;

         10. Subjects diagnosed with malignant tumors within 5 years;

         11. Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their
             ingredients;

         12. Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis
             (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases
             related to digestion and absorption or whose symptoms are likely to worsen due to
             intestinal gas;

         13. Subjects who participated in other clinical studies as Subjects within 60 days before
             this study (or before taking the investigational drugs);

         14. Subjects judged unfit for this study by investigators.