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Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489942
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date May 21, 2015
First Posted Date July 3, 2015
Last Update Posted Date December 24, 2020
Actual Study Start Date June 12, 2015
Actual Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2015)
Incidence of adverse drug reactions [ Time Frame: up to 156 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2015)
  • Change from baseline in HbA1c to the last- observation on treatment [ Time Frame: up to 156 weeks ]
  • Change from baseline in fasting plasma glucose to the last- observation on treatment [ Time Frame: up to 156 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
Official Title Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 3,000 Japanese patients with the assessment of 3-year completed administration
Condition Diabetes Mellitus, Type 2
Intervention Drug: Jardiance
Empagliflozin
Study Groups/Cohorts Jardiance
Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg
Intervention: Drug: Jardiance
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2020)
8145
Original Estimated Enrollment
 (submitted: July 1, 2015)
6000
Actual Study Completion Date December 4, 2020
Actual Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Exclusion criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT02489942
Other Study ID Numbers 1245.94
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2020