Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments oad, trazenta
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date July 2012
End date July 2017
Trial size 3300 participants
Trial identifier NCT01650259, 1218.95

Summary

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
oad
OAD except Trazenta tablets
trazenta
Linagliptin

Primary Outcomes

Measure
Incidence of adverse drug reactions (ADRs)
time frame: up to 156 weeks

Secondary Outcomes

Measure
The change from the baseline in HbA1c to the last-observation on treatment
time frame: up to 156 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion criteria: - Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group) - Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group) Exclusion criteria:

Additional Information

Official title Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets 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.