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Trial record 44 of 853 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT02489942
Recruitment Status : Active, not recruiting
First Posted : July 3, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

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 Type : Observational
Actual Enrollment : 8151 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
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


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




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 ]


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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:


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02489942     History of Changes
Other Study ID Numbers: 1245.94
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs