| Trial ID: | L5400 |
| Source ID: | NCT01650259
|
| Associated Drug: |
Oad
|
| Title: |
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01650259/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: OAD|DRUG: Trazenta
|
| Outcome Measures: |
Primary: Percentage of Participants With Adverse Drug Reactions (ADRs), An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied"., From start of the treatment until the end of this PMS, i.e. up to week 156 | Secondary: Change From Baseline in HbA1c at the Last Observation During the Observation Period., Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD)., Baseline and 156 week or last observation
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
4876
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2012-07-23
|
| Completion Date: |
2017-09-14
|
| Results First Posted: |
2019-05-10
|
| Last Update Posted: |
2019-09-18
|
| Locations: |
One Or Multiple Locations, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01650259
|
