» First Patient Enrolled in New Cardiovascular and Renal Outcomes Trial for Linagliptin in Type 2 Diabetes
First Patient Enrolled in New Cardiovascular and Renal Outcomes Trial for Linagliptin in Type 2 Diabetes
INGELHEIM, Germany - Wednesday, July 31st 2013 [ME NewsWire]
(BUSINESS WIRE) For Non-US and Non-UK Media
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 CARMELINA1 (CArdiovascular safety and Renal Microvascular 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.1 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.1 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.”
CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high vascular risk) is a long-term study investigating the efficacy and safety of linagliptin 5 mg once daily versus placebo on cardiovascular and renal microvascular outcomes in people with Type 2 Diabetes who are at risk of cardiovascular events. Adults with Type 2 Diabetes and previous CV complications and albuminuria (UACR ≥30mg/g) and/or evidence of microvascular related end-organ damage (eGFR 15-<45 with any UACR or eGFR ≥45-75 with an UACR >200mg/g) will be randomised into the study.
Linagliptin is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin tablets), as a once-daily tablet (5mg) that is used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).2,3
Please click on the link below for 'Notes to Editors' and 'References': http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/31_july_2013_diabetes.html
Dr. Petra Kienle
Launch and Established Products CVM
Boehringer Ingelheim GmbH
Phone: +49 (6132) 77-143877
Phone: +1 (317) 651-9116
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