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Completed

NCT Number: NCT02489942

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

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese 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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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 Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Exclusion criteria

None

Treatment and study plan

Jardiance

Drug

Empagliflozin

Primary outcomes

  1. Number of Patients With Adverse Drug Reactions (ADRs)

    Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.

    Number of patients with adverse drug reactions.

Secondary outcomes

  1. Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period

    Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.

    Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period

    Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.

    Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 3, 2015
Registry last updated
Feb 4, 2022

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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