Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
1 other identifier
observational
8,145
1 country
1
Brief Summary
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2015
CompletedStudy Start
First participant enrolled
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2020
CompletedResults Posted
Study results publicly available
February 4, 2022
CompletedFebruary 4, 2022
December 1, 2021
5.4 years
May 21, 2015
December 2, 2021
December 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Adverse Drug Reactions (ADRs)
Number of patients with adverse drug reactions.
From first drug administration until 7 days after last drug administration, up to 247 weeks.
Secondary Outcomes (2)
Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period
At start of treatment and at last observation on treatment, up to 246 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period
At start of treatment and at last observation on treatment, up to 246 weeks.
Study Arms (1)
Jardiance
Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg
Interventions
Eligibility Criteria
3,000 Japanese patients with the assessment of 3-year completed administration
You may qualify if:
- Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
Related Publications (1)
Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26.
PMID: 31769309DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Since this surveillance was an observational, non interventional study, it lacked the methodological rigour of a randomised control trial.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
July 3, 2015
Study Start
June 12, 2015
Primary Completion
November 11, 2020
Study Completion
December 4, 2020
Last Updated
February 4, 2022
Results First Posted
February 4, 2022
Record last verified: 2021-12