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

Astellas Pharma Inc11,412 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

11,412

Conditions

Type 2 Diabetes

Interventions

ipragliflozinDRUG

Tablets

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Chugoku, Japan

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Incidence of cardiovascular adverse events

Time frame: Up to 3 years

Incidence of malignant tumor

Time frame: Up to 3 years

Secondary Outcomes

Safety developed by adverse events and laboratory tests

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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