Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment sglt2 inhibitors
Sponsor Pharmaceuticals and Medical Devices Agency, Japan
Start date October 2014
End date May 2020
Trial size 18000 participants
Trial identifier NCT02284269, PMDA-A2602

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Incidence of adverse events
time frame: up to 3 years

Secondary Outcomes

Measure
Incidence of cardiovascular events
time frame: up to 3 years
Incidence of cancer
time frame: up to 3 years
The change from baseline in vital signs and laboratory data
time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
Incidence of other adverse events
time frame: up to 3 years
Incidence of drug-related adverse events
time frame: up to 3 years
Incidence of serious adverse events
time frame: up to 3 years
The change from baseline in HbA1c
time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
The change from baseline in Fasting Plasma Glucose
time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration

Eligibility Criteria

Male or female participants of any age.

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Additional Information

Official title Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Pharmaceuticals and Medical Devices Agency, Japan.