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 long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.
This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP group | Experimental | Concomitant administration of ASP1941 and α- glucosidase inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipragliflozin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | baseline and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose | baseline and 52 weeks | |
| Change from baseline in fasting serum insulin | baseline and 52 weeks | |
| Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| 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
Not provided
Not provided
Not provided
Not provided
Not provided
| alpha glucosidase inhibitor |
| Drug |
oral |
|
|
| for 52 weeks |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| TÅhoku | Japan |
| 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 |
| D065089 | Glycoside Hydrolase Inhibitors |
| D020909 | Acarbose |
| C045621 | miglitol |
| C102817 | voglibose |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided