Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients (STELLALONGTERM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02479399|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Drug: ipragliflozin|
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>
- Genital infection
- Urinary tract infection
- Polyuria and pollakiuria
- Adverse events related to a decrease in body fluids (dehydration, etc.)
- Malignant tumor
- Cardiovascular diseases
|Study Type :||Observational|
|Actual Enrollment :||11412 participants|
|Official Title:||Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)|
|Actual Study Start Date :||July 17, 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
- Incidence of cardiovascular adverse events [ Time Frame: Up to 3 years ]
- Incidence of malignant tumor [ Time Frame: Up to 3 years ]
- Safety developed by adverse events and laboratory tests [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479399
|Study Director:||Medical Director||Astellas Pharma Inc|