Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced the enrolment of the first patient in cardiovascular safety and renal microvascular outcome study with linagliptin, 5mg once daily in patients with type 2 diabetes mellitus at high vascular risk (CARMELINA).
Marketed as Tradjenta (linagliptin) tablets in the US, linagliptin is a once-daily 5mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes.
The cardiovascular (CV) and renal outcomes trial for linagliptin tablets is designed to find the effect of the once-daily dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in adults with type 2 diabetes at risk of major macro and microvascular events.
Medical City Dallas Diabetes and Endocrine Center director and study principal investigator Dr Julio Rosenstock said: "CARMELINA will investigate both cardiovascular and renal outcomes with a DPP-4 inhibitor."
More than 8,000 adults with type 2 diabetes will be enrolled in 24 countries at more than 500 sites globally in the CV study, which is expected to complete in 2018.
The study's endpoint is time to the first occurrence of either CV death, including fatal stroke and fatal myocardial infarction (MI), non-fatal MI, non-fatal stroke or hospitalisation for unstable angina pectoris.
The renal, or kidney, outcome is measured as time to first occurrence of renal death, sustained end-stage renal disease or sustained decrease of more than or equal to 50% in estimated glomerular filtration rate.
Boehringer Ingelheim Pharmaceuticals metabolic-clinical development and medical affairs vice-president Dr Christophe Arbet-Engels said: "Clinical trials like CARMELINA provide physicians with information they need to better understand the safety and efficacy of linagliptin, so that they can appropriately treat people with uncontrolled T2D."
Image: Boehringer Ingelheim and Eli Lilly initiate post-marketing trial with a planned enrolment of more than 8,000 adults with type 2 diabetes in 24 countries. Photo: courtesy of Guanaco152003.