Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Astellas Pharma Korea, Inc. |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipragliflozin | Experimental | Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral administration of Ipragliflozin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between change of HbA1c and urinary glucose excretion | Baseline and week 12 |
| 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 |
Not provided
Inclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D004700 | Endocrine System Diseases |