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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Ipragliflozin (SGLT2 inhibitor)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02317484

TRIEND1413

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

231 participants in 1 patient group

Ipragliflozin (SGLT2 inhibitor)

Treatment:

Drug: Ipragliflozin (SGLT2 inhibitor)