Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [up to 3 years]
Secondary Outcome Measures
- Incidence of cardiovascular events [up to 3 years]
- Incidence of cancer [up to 3 years]
- The change from baseline in vital signs and laboratory data [Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration]
- Incidence of other adverse events [up to 3 years]
- Incidence of drug-related adverse events [up to 3 years]
- Incidence of serious adverse events [up to 3 years]
- The change from baseline in HbA1c [Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration]
- The change from baseline in Fasting Plasma Glucose [Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration]
Eligibility Criteria
Criteria
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pharmaceuticals and Medical Devices Agency, Japan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMDA-A2602