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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02367131
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 423
• Location: 1
• Actual Duration (Months): 19.1
• Patients Per Site Per Month: 22.2

Study Details

Study Description

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	Phase
Diabetes Mellitus, Type 2	Drug: Jardiance

Study Design

• 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: Feb 24, 2015
• Actual Primary Completion Date: Sep 27, 2016
• Actual Study Completion Date: Sep 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
Jardiance	Drug: Jardiance; Empagliflozin

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Adverse Drug Reactions (ADRs) [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NISND Center	One Or Multiple Investigational Sites		Japan

Sponsors and Collaborators

• Boehringer Ingelheim
• Eli Lilly and Company

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02367131
• Other Study ID Numbers: 1245.98
• First Posted: Feb 20, 2015
• Last Update Posted: Jun 20, 2018
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Empagliflozin

Study Results

Participant Flow

Pre-assignment Detail	Non-interventional, prospective, observational, single arm based on new data collection

Arm/Group Title	Jardiance
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
COMPLETED	201
NOT COMPLETED	222

Baseline Characteristics

Arm/Group Title	Jardiance
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 Participants	419
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	71.8 (5.5)
Sex: Female, Male (Count of Participants)
Female	172 41.1%
Male	247 58.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Adverse Drug Reactions (ADRs)
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

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	Jardiance
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.
Measure Participants	419
Number [Percentage of participants]	19.09 4.6%

2. Secondary Outcome

Title	Change From Baseline in HbA1c at the Last Observation During the Observation Period
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

Outcome Measure Data

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
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.
Measure Participants	386
Mean (Standard Deviation) [Percentage]	-0.36 (1.03)

3. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period
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

Outcome Measure Data

Analysis Population Description

Efficacy set

Arm/Group Title	Jardiance
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.
Measure Participants	240
Mean (Standard Deviation) [mg/dL]	-8.4 (45.6)

Adverse Events

Time Frame	From first drug administration until 7 days after last drug adminstration, up to 52 weeks
Arm/Group Title	Jardiance
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Jardiance
	Affected / at Risk (%)	# Events
Total	6/419 (1.4%)
Cardiac disorders
Atrial flutter	1/419 (0.2%)
Stress cardiomyopathy	1/419 (0.2%)
Eye disorders
Age-related macular degeneration	1/419 (0.2%)
Hepatobiliary disorders
Hepatic cirrhosis	1/419 (0.2%)
Infections and infestations
Pneumonia	1/419 (0.2%)
Investigations
Blood glucose increased	1/419 (0.2%)
Other (Not Including Serious) Adverse Events
	Jardiance
	Affected / at Risk (%)	# Events
Total	0/419 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.