This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Sponsor AstraZeneca
Start date October 2014
End date July 2019
Trial size 6000 participants
Trial identifier NCT02200666, D1692C00014


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Adverse event incidence
time frame: from baseline to 3 years

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.