Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)

* Development of ADRs specified as Key Investigation Items and the risk factors * Contributing factors possibly having an impact on the safety and efficacy * Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

Adverse event incidence

Time frame: from baseline to 3 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jul 25, 2014
Registry last updated: Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed