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The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suglat group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suglat® | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the occurrence of urinary tract infection | 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time) | |
| Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc). |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly patients with type 2 diabetes who used Suglat Tablets within 3 months from its launch
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26800061 | Derived | Terauchi Y, Yokote K, Nakamura I, Sugamori H. Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study. Expert Opin Pharmacother. 2016;17(4):463-71. doi: 10.1517/14656566.2016.1145668. Epub 2016 Feb 5. |
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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 |
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| 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time) |
| Investigate the occurrence of adverse drug reactions other than the above | 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time) |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| Shikoku | Japan |
| Tōhoku | Japan |
| D004700 | Endocrine System Diseases |