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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02284269
• Other study ID #: PMDA-A2602
• Status: Active, not recruiting
• Phase: N/A
• First received: November 3, 2014
• Last updated: March 31, 2016
• Start date: October 2014

Study information

• Verified date: March 2016
• Source: Pharmaceuticals and Medical Devices Agency, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18000
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• SGLT2 Inhibitors
Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaceuticals and Medical Devices Agency, Japan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		up to 3 years	No
Secondary	Incidence of cardiovascular events		up to 3 years	No
Secondary	Incidence of cancer		up to 3 years	No
Secondary	The change from baseline in vital signs and laboratory data		Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration	No
Secondary	Incidence of other adverse events		up to 3 years	No
Secondary	Incidence of drug-related adverse events		up to 3 years	No
Secondary	Incidence of serious adverse events		up to 3 years	No
Secondary	The change from baseline in HbA1c		Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration	No
Secondary	The change from baseline in Fasting Plasma Glucose		Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration	No