Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02200666
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)

* Development of ADRs specified as Key Investigation Items and the risk factors

* Contributing factors possibly having an impact on the safety and efficacy

* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-10-03
• Primary Completion: 2019-09-09
• Study Completion: 2019-09-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7793

Inclusion Criteria

Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.

Exclusion Criteria

N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	from baseline to 3 years

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan