PMS of Trazenta on the Long-term Use as Add-on Therapy

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Trazenta

• Registration Number: NCT01904383
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Status Verified: 2019-09
• Results First Submitted: 2019-09-06
• Results First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Results First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4057

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trazenta	Trazenta	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Drug Related Adverse Events	From first drug administration until last drug administration, up to approximately 156 weeks.	Percentage of participants with drug related adverse events.

Secondary Outcome Measures

Name	Time	Method
The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)	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).