Trials / Completed
CompletedNCT02479399
Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients
Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11,412 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this survey is to confirm the safety of Suglat Tablets
Detailed description
The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years. Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors. Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets. \<Items of interest\> * Hypoglycemia * Genital infection * Urinary tract infection * Polyuria and pollakiuria * Adverse events related to a decrease in body fluids (dehydration, etc.) * Malignant tumor * Cardiovascular diseases
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ipragliflozin | Tablets |
Timeline
- Start date
- 2014-07-17
- Primary completion
- 2018-10-16
- Completion
- 2018-10-16
- First posted
- 2015-06-24
- Last updated
- 2024-10-22
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02479399. Inclusion in this directory is not an endorsement.