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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Ipragliflozin (SGLT2 inhibitor)

• Registration Number: NCT02317484
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-16
• Primary Completion: 2017-11-21
• Study Completion: 2018-02-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ipragliflozin (SGLT2 inhibitor)	Ipragliflozin (SGLT2 inhibitor)	-

Primary Outcome Measures

Name	Time	Method
HbA1c change level	After 52 weeks from the time of treatment initiation

Secondary Outcome Measures

Name	Time	Method
Sugar metabolism and body composition change levels	After 12, 24, 36, 52 weeks from the time of the start of treatment	Change levels of the followings after 12, 24, 36, 52 weeks from the time of treatment initiation: HbA1c, blood glucose (both at fasting and after eating), glycoalbumin, body weight, BMI, serum lipid (TC、LDL-C、HDL-C、TG), blood pressure (both systolic and diastolic)
HbA1c achievement rate	After 12, 24, 36, 52 weeks from the time of treatment initiation	The rate of less than HbA1c7.0% achievement 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	Changes of the body composition examined by DEXA (Dual-energy X-ray absorptiometry) method and visceral fat examined by CT scan after 24 and 52 weeks from the time of treatment initiation

Trial Locations

Locations (1)

Osaka Saiseikai Nakatsu Hospital; 🇯🇵 Osaka, Japan