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Trial record 61 of 913 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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Diabetes Mellitus, Type 2
Intervention Drug: Jardiance
Enrollment 423
Recruitment Details  
Pre-assignment Details Non-interventional, prospective, observational, single arm based on new data collection
Arm/Group Title Jardiance
Hide Arm/Group Description Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
Period Title: Overall Study
Started 423 [1]
Completed 201
Not Completed 222
Reason Not Completed
Adverse Event             64
No visit since the first visit             4
Request by patient             54
Improvement/remission             2
No change/progressive disease             78
Other than stated above             20
[1]
Started are the treated patients
Arm/Group Title Jardiance
Hide Arm/Group Description Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
Overall Number of Baseline Participants 419
Hide Baseline Analysis Population Description
Safety Set : This analysis set that included all elderly patients who had received treatment of JARDIANCE® Tablet at least one time except those who were found to have no observation after enrolment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 419 participants
71.8  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419 participants
Female
172
  41.1%
Male
247
  58.9%
1.Primary Outcome
Title Percentage of Patients With Adverse Drug Reactions (ADRs)
Hide Description Percentage of patients with drug related Adverse events
Time Frame From first drug administration until 7 days after last drug adminstration, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title Jardiance
Hide Arm/Group Description:
Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
Overall Number of Participants Analyzed 419
Measure Type: Number
Unit of Measure: Percentage of participants
19.09
2.Secondary Outcome
Title Change From Baseline in HbA1c at the Last Observation During the Observation Period
Hide Description Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period
Time Frame Baseline and last observation on treatment, up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Set: This analysis set is a subset of the safety set, which included all patients in the “safety set” except those who had no available efficacy data.
Arm/Group Title Jardiance
Hide Arm/Group Description:
Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
Overall Number of Participants Analyzed 386
Mean (Standard Deviation)
Unit of Measure: Percentage
-0.36  (1.03)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set
Arm/Group Title Jardiance
Hide Arm/Group Description:
Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: mg/dL
-8.4  (45.6)
Time Frame From first drug administration until 7 days after last drug adminstration, up to 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Jardiance
Hide Arm/Group Description Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg.
All-Cause Mortality
Jardiance
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Jardiance
Affected / at Risk (%)
Total   6/419 (1.43%) 
Cardiac disorders   
Atrial flutter  1  1/419 (0.24%) 
Stress cardiomyopathy  1  1/419 (0.24%) 
Eye disorders   
Age-related macular degeneration  1  1/419 (0.24%) 
Hepatobiliary disorders   
Hepatic cirrhosis  1  1/419 (0.24%) 
Infections and infestations   
Pneumonia  1  1/419 (0.24%) 
Investigations   
Blood glucose increased  1  1/419 (0.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Jardiance
Affected / at Risk (%)
Total   0/419 (0.00%) 
The study was conducted in an unblinded manner and without controls. The sample size was not sufficient for rare ADRs. Some priority survey items were not reported, therefore incidence could not be estimated
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02367131     History of Changes
Other Study ID Numbers: 1245.98
First Submitted: February 13, 2015
First Posted: February 20, 2015
Results First Submitted: September 11, 2017
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018