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

Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: JARDIANCE®

• Study Type: Observational
• Enrollment (Actual): 419

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • NISND Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
JARDIANCE®	Drug: JARDIANCE®; JARDIANCE®; Other Names: Empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period	Change from baseline in HbA1c (%) at the last observation during the observation period is reported. Change from baseline was calculated as: HbA1c value at the last observation - HbA1c baseline value.	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	Change from baseline in fasting plasma glucose (FPG) at the last observation during the observation period. Change from baseline was calculated as: FPG value at the last observation - FPG baseline value.	Baseline and last observation on treatment, up to week 52.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2015
• Primary Completion (Actual): September 27, 2016
• Study Completion (Actual): September 27, 2016

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimated): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245.98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR