NCT02297620

The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,687 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.

Detailed description

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. 1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors. 2. Investigate the occurrence of urinary tract infection. 3. 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). 4. Investigate the occurrence of adverse drug reactions other than the above. 5. Factors that may possibly influence the safety of Suglat Tablets.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Suglat®	oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-11-21
• Last updated: 2015-10-15

Locations

8 sites across 1 country: Japan