Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
SGLT2 Inhibitors
Sponsored by
About this trial
This is an observational trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Sites / Locations
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Incidence of cardiovascular events
Incidence of cancer
The change from baseline in vital signs and laboratory data
Incidence of other adverse events
Incidence of drug-related adverse events
Incidence of serious adverse events
The change from baseline in HbA1c
The change from baseline in Fasting Plasma Glucose
Full Information
NCT ID
NCT02284269
First Posted
November 3, 2014
Last Updated
March 31, 2016
Sponsor
Pharmaceuticals and Medical Devices Agency, Japan
1. Study Identification
Unique Protocol Identification Number
NCT02284269
Brief Title
Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Official Title
Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Study Type
Observational
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaceuticals and Medical Devices Agency, Japan
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Enrollment
18000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SGLT2 Inhibitors
Intervention Description
Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Incidence of cardiovascular events
Time Frame
up to 3 years
Title
Incidence of cancer
Time Frame
up to 3 years
Title
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
Title
Incidence of other adverse events
Time Frame
up to 3 years
Title
Incidence of drug-related adverse events
Time Frame
up to 3 years
Title
Incidence of serious adverse events
Time Frame
up to 3 years
Title
The change from baseline in HbA1c
Time Frame
Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
Title
The change from baseline in Fasting Plasma Glucose
Time Frame
Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Study Population Description
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Sampling Method
Non-Probability Sample
12. IPD Sharing Statement
Learn more about this trial
Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
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