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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: TRADIANCE® Combination Tablets AP; Drug: TRADIANCE® Combination Tablets BP

• Registration Number: NCT03761797
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-01-15
• Primary Completion: 2021-03-10
• Study Completion: 2021-04-27
• Status Verified: 2022-04
• Results First Submitted: 2022-04-20
• Results First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Results First Posted: 2023-01-23
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1164

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with type 2 Diabetes Mellitus	TRADIANCE® Combination Tablets BP	-
Subjects with type 2 Diabetes Mellitus	TRADIANCE® Combination Tablets AP	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions (ADRs)	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.

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd; 🇯🇵 Tokyo, Japan