Forxiga Tablets Specific Clinical Experience Investigation for Elderly

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT02200627

D1692C00015

Details and patient eligibility

About

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

• 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

Enrollment: 1,724 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients treated with Forxiga for the first time during three months after the launch due to type 2 diabetes mellitus, which is the indication of the drug, aged 65 or over at the time when Forxiga was started.

In addition, patients receiving the study drug of Forxiga before the launch should be included also.

Exclusion Criteria: N/A