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

N/ACompletedNCT01904383

Boehringer Ingelheim4,057 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,057

Conditions

Diabetes Mellitus, Type 2

Interventions

TrazentaDRUG

1 tablet of 5 mg Trazenta tablets once daily

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria: Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included. Exclusion criteria: None

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Drug Related Adverse Events

Percentage of participants with drug related adverse events.

Time frame: From first drug administration until last drug administration, up to approximately 156 weeks.

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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