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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.
Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1941 group | Experimental | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipragliflozin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose | Before and at 4-, 8-, 12-, 16-, 20- and 24-week | |
| Change in fasting serum insulin | Before and at 4-, 8-, 12-, 16-, 20- and 24-week | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chūbu | Japan | |||||
Not provided
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
Not provided
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C572941 | ipragliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in waist circumference |
| Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Change in body weight | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Change in urine glucose | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs | 24 weeks |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| TÅhoku | Japan |