The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients (STELLA-ELDER)

Astellas

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Suglat®

Study type: Observational

Funder types: Industry

Identifiers

NCT02297620

SGL001

Details and patient eligibility

About

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

Full 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.

Enrollment: 8,687 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes who used Suglat Tablets within 3 months from its launch

Exclusion criteria

• off-label use patients

Trial design

8,687 participants in 1 patient group

Suglat group

Treatment:

Drug: Suglat®