Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients (STELLALONGTERM)

Astellas

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: ipragliflozin

Study type: Observational

Funder types: Industry

Identifiers

NCT02479399

SGL002

Details and patient eligibility

About

The objective of this survey is to confirm the safety of Suglat Tablets

Full 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

Enrollment: 11,412 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Exclusion criteria

• off-label use patients

Trial design

11,412 participants in 1 patient group

Suglat group

Description:

Tablets

Treatment:

Drug: ipragliflozin