Foxiga Korea Local Phase 4 Study

• Status: Completed
• Trial end date: 2018-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Glimepiride; Metformin

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.