This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment trazenta
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date July 2013
End date June 2018
Trial size 3000 participants
Trial identifier NCT01904383, 1218.147


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
1 tablet of 5 mg Trazenta tablets once daily

Primary Outcomes

The primary endpoint to assess safety of Trazenta Tablets is the number (%) of patients with drug related adverse events
time frame: up to 156 weeks

Secondary Outcomes

Incidence of serious adverse events (SAEs)
time frame: up to 156 weeks
Incidence of cardiovascular events
time frame: up to 156 weeks
The change between baseline and observation period in Haemoglobin A1c (HbA1c)
time frame: up to 156 weeks

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.