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Trial record 61 of 950 for:    tablet | Japan

Daily Use of JARDIANCE® Tablets in Japanese Elderly 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: 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

Tracking Information
First Submitted Date February 13, 2015
First Posted Date February 20, 2015
Results First Submitted Date September 11, 2017
Results First Posted Date June 20, 2018
Last Update Posted Date June 20, 2018
Actual Study Start Date February 24, 2015
Actual Primary Completion Date September 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2017)
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
Original Primary Outcome Measures
 (submitted: February 13, 2015)
Incidence of adverse drug reactions [ Time Frame: up to 52 weeks ]
Change History Complete list of historical versions of study NCT02367131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 11, 2017)
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: February 13, 2015)
  • Change from baseline in HbA1c to the last- observation on treatment [ Time Frame: up to 52 weeks ]
  • Change from baseline in Fasting plasma glucose to the last- observation on treatment [ Time Frame: up to 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Official Title Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus
Brief Summary Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly 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 All patients start taking JARDIANCE® Tablets within 3 months after launch will be included.
Condition Diabetes Mellitus, Type 2
Intervention Drug: Jardiance
Empagliflozin
Study Groups/Cohorts Jardiance
Intervention: Drug: Jardiance
Publications * Not Provided

*   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: February 24, 2017)
423
Original Estimated Enrollment
 (submitted: February 13, 2015)
720
Actual Study Completion Date September 27, 2016
Actual Primary Completion Date September 27, 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (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  
 
Administrative Information
NCT Number NCT02367131
Other Study ID Numbers 1245.98
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 September 2017