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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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