PMS of Trazenta on the Long-term Use as Add-on Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01904383|
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: Trazenta|
|Study Type :||Observational|
|Actual Enrollment :||4057 participants|
|Official Title:||Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||July 1, 2013|
|Actual Primary Completion Date :||October 4, 2018|
|Actual Study Completion Date :||October 4, 2018|
1 tablet of 5 mg Trazenta tablets once daily
- Percentage of Participants With Drug Related Adverse Events [ Time Frame: From first drug administration until last drug administration, up to approximately 156 weeks. ]Percentage of participants with drug related adverse events.
- The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) [ Time Frame: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. ]The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904383
|Multiple Locations, Japan|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|