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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TRADIANCE® Combination Tablets AP

Drug

Fixed dose combination

TRADIANCE® Combination Tablets BP

Drug

Fixed dose combination

Primary outcomes

Number of Participants With Adverse Drug Reactions (ADRs)

Time frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.

The number of participants with adverse drug reactions is reported.

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 TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Dec 3, 2018
Registry last updated: Jan 23, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed