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The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lowest dose |
|
| 2 | Experimental | Low-middle dose |
|
| 3 | Experimental | High-middle dose |
|
| 4 | Experimental | Highest dose |
|
| 5 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipragliflozin | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c level | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose level | 12 Weeks | |
| Safety | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31606880 | Derived | Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12. | |
| 25411597 | Derived |
| 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 |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| Placebo | Drug | Oral |
|
| Chūbu |
| Japan |
| Hokkaidou | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| Tōhoku | Japan |
| Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28. |