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

NCT ID: NCT02489942

Last Updated: 2022-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-12

Study Completion Date

2020-12-04

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Jardiance

Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg

Jardiance

Intervention Type DRUG

Empagliflozin

Interventions

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Jardiance

Empagliflozin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

References

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Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26.

Reference Type DERIVED
PMID: 31769309 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1245.94

Identifier Type: -

Identifier Source: org_study_id

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