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Completed

NCT Number: NCT02367131

Daily Use of JARDIANCE® Tablets in Japanese 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NISND Center

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JARDIANCE®

Drug

JARDIANCE®

Other names: Empagliflozin

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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 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.

  2. 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 (FPG) at the last observation during the observation period.

    Change from baseline was calculated as: FPG value at the last observation - FPG baseline value.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2015
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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