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 APDrug: 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
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
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Exclusion Criteria
None
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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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nippon Boehringer Ingelheim Co., Ltd
🇯🇵Tokyo, Japan