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Trial record 61 of 914 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT02367131
Recruitment Status : Completed
First Posted : February 20, 2015
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

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

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Study Type : Observational
Actual Enrollment : 423 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : February 24, 2015
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : September 27, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Jardiance Drug: Jardiance
Empagliflozin




Primary Outcome Measures :
  1. Percentage of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: From first drug administration until 7 days after last drug adminstration, up to 52 weeks ]
    Percentage of patients with drug related Adverse events


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at the Last Observation During the Observation Period [ Time Frame: Baseline and last observation on treatment, up to week 52 ]
    Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period

  2. Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period [ Time Frame: Baseline and last observation on treatment, up to week 52 ]
    Change from baseline in Fasting plasma glucose at the last observation during the observation period.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients start taking JARDIANCE® Tablets within 3 months after launch will be included.
Criteria

Inclusion criteria:

Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan

Exclusion criteria:

None


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): NCT02367131


Locations
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Japan
NISND Center
One Or Multiple Investigational Sites, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02367131     History of Changes
Other Study ID Numbers: 1245.98
First Posted: February 20, 2015    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: September 2017

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