Boehringer Ingelheim and Lilly initiate post-marketing trial in more than 8,000 adults with Type 2 Diabetes in 24 countries
Boehringer Ingelheim (BI) and Eli Lilly and Company today announced enrollment of the first patient into a cardiovascular and renal outcomes trial for linagliptin (Trajenta®). The CARMELINA (CArdiovascular safety and RenalMicrovascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high vascular risk) trial will investigate the once daily dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, on cardiovascular and renal microvascular outcomes in adults with Type 2 Diabetes at risk of cardiovascular and renal events.
Linagliptin (5 mg, once daily) is a once-daily tablet that is used along with diet and exercise and other drug therapies to improve glycaemic control in adults with Type 2 Diabetes.
“Diabetes is a major risk factor for cardiovascular disease, as well as a leading cause of chronic renal failure,” said Dr. Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center at Medical City in Dallas and Principal Investigator of the study. “CARMELINA will investigate both cardiovascular and renal safety with a DPP-4 inhibitor on adverse cardiovascular and renal outcomes.”
The CARMELINA study will include more than 8,000 adults with Type 2 Diabetes in 24 countries at more than 500 sites around the world. The primary endpoint will be time to the first occurrence of either CV death (including fatal stroke and fatal MI); non-fatal MI; non-fatal stroke; or hospitalisation for unstable angina pectoris (AP). The renal outcome is measured as a composite of renal death, sustained end-stage renal disease and sustained decrease of ≥50 percent eGFR. The study is expected to complete in 2018.
“We are delighted that the first patient has now been enrolled in CARMELINA and look forward to continued recruitment and patient follow-up,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The initiation of this trial reinforces our ongoing commitment to evaluate the efficacy and safety of linagliptin, ensuring that treating physicians are provided with all required information to support the use of the treatment in clinical practice as appropriate.”