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

NCT ID: NCT02284269

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 18000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Interventions

SGLT2 Inhibitors

Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmaceuticals and Medical Devices Agency, Japan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PMDA-A2602

Identifier Type: -

Identifier Source: org_study_id