Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01650259|
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : May 10, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: OAD Drug: Trazenta|
|Study Type :||Observational|
|Actual Enrollment :||4876 participants|
|Official Title:||Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||July 23, 2012|
|Actual Primary Completion Date :||September 5, 2017|
|Actual Study Completion Date :||September 14, 2017|
|Oral antidiabetic drug (OAD)||
OAD except Trazenta tablets
- Percentage of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: From start of the treatment until the end of this PMS, i.e. up to week 156 ]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".
- Change From Baseline in HbA1c at the Last Observation During the Observation Period. [ Time Frame: Baseline and 156 week or last observation ]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).
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): NCT01650259
|One Or Multiple Locations, Japan|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|