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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 site in 1 country231 target enrollmentNovember 2014

ConditionsDiabetes Mellitus, Type 2

InterventionsIpragliflozin (SGLT2 inhibitor)

DrugsIpragliflozin (SGLT2 inhibitor)

Overview

Phase: Not Applicable
Intervention: Ipragliflozin (SGLT2 inhibitor)
Conditions: Diabetes Mellitus, Type 2
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Enrollment: 231
Locations: 1
Primary Endpoint: HbA1c change level
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

February 28, 2018

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
•Patients with changes within +- 0.5% of HbA1c
•Patients with the variation of 6.5% =\< HbA1C =\<10%
•Patients with written informed consents
•Patients whose BMI is =\>20kg/m2

Exclusion Criteria

•Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
•Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
•Patients with severe infection, in the perioperative period or severe trauma
•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)
•Patients with severe hepatic impairment (judged by the attending doctor)
•Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent
•Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy
•Patients with neuropathic bladder or dysuria
•Patients under treatment with diuretic
•Patients under SGLT2 treatment at the kickoff point of the study

Arms & Interventions

Ipragliflozin (SGLT2 inhibitor)

Intervention: Ipragliflozin (SGLT2 inhibitor)

Outcomes

Primary Outcomes

HbA1c change level

Time Frame: After 52 weeks from the time of treatment initiation

Secondary Outcomes

Sugar metabolism and body composition change levels(After 12, 24, 36, 52 weeks from the time of the start of treatment)
HbA1c achievement rate(After 12, 24, 36, 52 weeks from the time of treatment initiation)
Body composition and visceral fat change levels(After 24 and 52 weeks from the time of treatment initiation)