Foxiga Korea Local Phase 4 Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Glimepiride
Intervention description: Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment; Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
Intervention MeSH terms: Dapagliflozin; Glimepiride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: DM

Summary:

      To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month,
      randomised, open-label, parallel-group, multi-centre phase IV study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)

          2. Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)

          3. Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to
             randomization

          4. Written informed consent

          5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks
             after intake of the last dose.

               -  WOCBP must have a negative urine pregnancy test at screening visit WOCBP include
                  any female who has experienced menarche and who has not undergone successful
                  surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral
                  oophorectomy) or is not postmenopausal.

               -  WOCBP must be willing to use a medically accepted method of contraception that is
                  considered reliable in the judgment of the Investigator.

        Exclusion Criteria:

          1. Type 1 diabetes or history of diabetic ketoacidosis

          2. Pregnant or breast-feeding patients

          3. eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.

          4. Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of
             normal) on visit 1.

          5. Acute coronary syndrome, stroke or TIA within 3 months prior to randomization

          6. Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to
             randomization; any treatment leading to unstable body weight. (Unstable body weight is
             considered reliable in the judgment of the Investigator.)

          7. History of bladder cancer or history of radiation therapy to the lower abdomen or
             pelvis at any time

          8. History of any other malignancy within 5 years (with the exception of successfully
             treated non-melanoma skin cancers)

          9. History of alcohol or drug abuse judged by physician within 3 months prior to
             randomization

         10. Concomitant participation in any other clinical study.