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| Name | Class |
|---|---|
| Osaka Saiseikai Nakatsu Hospital | OTHER |
| Astellas Pharma Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipragliflozin (SGLT2 inhibitor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipragliflozin (SGLT2 inhibitor) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change level | After 52 weeks from the time of treatment initiation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic and hospital
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| Name | Affiliation | Role |
|---|---|---|
| Haruo Nishimura | Osaka Saiseikai Nakatsu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Saiseikai Nakatsu Hospital | Osaka | 530-0012 | Japan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| 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 |
| D004700 | Endocrine System Diseases |
| D045505 | Physiological Effects of Drugs |