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

NCT02367131 | Completed Results

• 1 other identifier: 1245.98
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Adverse Drug Reactions (ADRs)

  ADRs were defined as those adverse events for which the causal relationship was considered "Possibility high " or "Possibility low" or "Unknown" by the principal investigator, where: * Possibility high: There is a reasonable causal relationship between JARDIANCE® tablets administered and the adverse events (AE); * Possibility low: It is probably/possibly that there is a reasonable causal relationship between JARDIANCE® tablets administered and the AE; * Unknown: Cannot be judged because information is insufficient or contradictory. Percentages were rounded to two decimal places.

  From first drug administration until 7 days after last drug adminstration, up to 52 weeks.

Secondary Outcomes (2)

• 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 Fasting Plasma Glucose at the Last Observation During the Observation Period

  Baseline and last observation on treatment, up to week 52.

Study Arms (1)

JARDIANCE®

Drug: JARDIANCE®

Interventions

JARDIANCE® DRUG

JARDIANCE®

Also known as: Empagliflozin

JARDIANCE®

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients start taking JARDIANCE® Tablets within 3 months after launch will be included.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

NISND Center

Multiple Locations, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and 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

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: February 24, 2015
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: March 8, 2024
• Results First Posted: June 20, 2018

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (1)