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The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| before meal group | Experimental | ASP1941 will be administered before meal |
|
| after meal group | Experimental | ASP1941 will be administered after meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipragliflozin | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | For 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | For 52 weeks | |
| Fasting serum insulin | For 52 weeks | |
| Plasma levels of ASP1941 for population PK analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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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/.
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| 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 |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
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| For 52 weeks |
| Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs | For 52 weeks |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| Tōhoku | Japan |