A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

NCT ID: NCT03761797

Last Updated: 2023-01-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-04-27

Brief Summary

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Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

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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Subjects with type 2 Diabetes Mellitus

TRADIANCE® Combination Tablets AP

Intervention Type DRUG

Fixed dose combination

TRADIANCE® Combination Tablets BP

Intervention Type DRUG

Fixed dose combination

Interventions

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TRADIANCE® Combination Tablets AP

Fixed dose combination

Intervention Type DRUG

TRADIANCE® Combination Tablets BP

Fixed dose combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
* Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment

Exclusion Criteria

None
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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Rie Ikeda, 81364172200

Role: STUDY_CHAIR

[email protected]

Locations

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Nippon Boehringer Ingelheim Co., Ltd

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16.

Reference Type DERIVED
PMID: 35946927 (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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1275-0026

Identifier Type: -

Identifier Source: org_study_id

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