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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trazenta

Drug

1 tablet of 5 mg Trazenta tablets once daily

Primary outcomes

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.

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

Eli Lilly and Company

Registry information

Official study title

Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Jul 22, 2013
Registry last updated: Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed