Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin

Study Overview
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Brief Summary
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The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Oral administration of Ipragliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who has written informed consent Subjects who are diagnosed as type 2 diabetes mellitus Subjects who are 20 to 70 years old Subjects on a stable diet and exercise at least 8 weeks prior to the study participation Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor) Exclusion Criteria: Type 1 DM Gestational DM Diabetic ketoacidosis CKD stage 3B-5 (eGFR 45) Severe infection, serious trauma, or perioperative period Known or suspected hypersensitivity to ipragliflozin Symptomatic urogenital infection Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer) Under the therapeutic intervention and/or another clinical study using IP drug Hepatic disease ( 3 times of upper normal limit of AST or ALT) Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia Drugs not allowed for concomitant use Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening Insulin within 60 days prior to screening Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate GLP-1 agonist (except for exenatide) within 60 days prior to screening Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening Subjects who are not eligible to the study according to an investigator's decision Inability to read the consent form Pregnancy, lactation, or plan to get pregnant during the study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipragliflozin<br>Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks | Drug: Oral administration of Ipragliflozin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change of HbA1c and urinary glucose excretion |  | Baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index) |  | Baseline and week 12 | 
| Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index) |  | Baseline and week 12 | 
| Change of HbA1c |  | Baseline and week 12 | 
| Chang e of fasting glucose |  | Baseline and week 12 | 
| Change of waist circumference |  | Baseline and week 12 | 
| Percentage of subjects achieving the target HbA1c(<6.5%) |  | week 12 |