Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Pharmaceuticals and Medical Devices Agency, Japan

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: SGLT2 Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT02284269

PMDA-A2602

Details and patient eligibility

About

The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.

In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.

Enrollment: 18,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors