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

March 31, 2016 updated by: Pharmaceuticals and Medical Devices Agency, Japan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

18000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Description

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of cardiovascular events
Time Frame: up to 3 years
up to 3 years
Incidence of cancer
Time Frame: up to 3 years
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
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
up to 3 years
Incidence of drug-related adverse events
Time Frame: up to 3 years
up to 3 years
Incidence of serious adverse events
Time Frame: up to 3 years
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
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
Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaceuticals and Medical Devices Agency, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMDA-A2602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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