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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Ipragliflozin (SGLT2 inhibitor)


Participation Criteria
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Eligibility Criteria
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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 Patients with a history of hypersensitivity to SGLT2 inhibitors Patients who are judged ineligible by the principal investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ipragliflozin (SGLT2 inhibitor)<br> | Drug: Ipragliflozin (SGLT2 inhibitor)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change level |  | After 52 weeks from the time of treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sugar metabolism and body composition change levels | 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) | After 12, 24, 36, 52 weeks from the time of the start of treatment | 
| HbA1c achievement rate | The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation | After 12, 24, 36, 52 weeks from the time of treatment initiation | 
| Body composition and visceral fat change levels | 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 | After 24 and 52 weeks from the time of treatment initiation |