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

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: ipragliflozin

• Registration Number: NCT02479399
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-07-17
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-16
• Status Verified: 2018-12
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11412

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suglat group	ipragliflozin	Tablets

Primary Outcome Measures

Name	Time	Method
Incidence of cardiovascular adverse events	Up to 3 years
Incidence of malignant tumor	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Safety developed by adverse events and laboratory tests	Up to 3 years