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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

Study Description
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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

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Jardiance

Study Design
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Study Type : Observational
Actual Enrollment : 8145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : June 12, 2015
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Jardiance
Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg
 Drug: Jardiance
Empagliflozin


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in HbA1c to the last- observation on treatment [ Time Frame: up to 156 weeks ]
  2. Change from baseline in fasting plasma glucose to the last- observation on treatment [ Time Frame: up to 156 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3,000 Japanese patients with the assessment of 3-year completed administration
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489942


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02489942    
Other Study ID Numbers: 1245.94
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs