Forxiga Tablets Specific Clinical Experience Investigation for Elderly

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

* 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 during three months after the launch due to type 2 diabetes mellitus, which is the indication of the drug, aged 65 or over at the time when Forxiga was started.

In addition, patients receiving the study drug of Forxiga before the launch should be included also.

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

Adverse event incidence

Time frame: from baseline to 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 25, 2014
Registry last updated: Feb 23, 2017

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