Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes

• Status: Completed
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborators: Astellas Pharma Inc; Osaka Saiseikai Nakatsu Hospital
• Treatments: Ipragliflozin; Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

1. Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs

2. Patients with changes within +- 0.5% of HbA1c

3. Patients with the variation of 6.5% =< HbA1C =<10%

4. Patients with written informed consents

5. Patients whose BMI is =>20kg/m2

Exclusion Criteria:

1. Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes

2. Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months

3. Patients with severe infection, in the perioperative period or severe trauma

4. Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL)

5. Patients with severe hepatic impairment (judged by the attending doctor)

6. Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent

7. Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy

8. Patients with neuropathic bladder or dysuria

9. Patients under treatment with diuretic

10. Patients under SGLT2 treatment at the kickoff point of the study

11. Patients with a history of hypersensitivity to SGLT2 inhibitors

12. Patients who are judged ineligible by the principal investigator