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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
Pharmaceuticals and Medical Devices Agency, Japan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers
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

    First Posted
    November 3, 2014
    Last Updated
    March 31, 2016
    Sponsor
    Pharmaceuticals and Medical Devices Agency, Japan
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    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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