Date: 2013-07-31
Type of information:
phase:
Announcement: enrollment of the first patient
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA)
Product: linagliptin (Tradjenta® in the US and Trajenta® in Europe)
Action
mechanism: Tradjenta® is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country: USA, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Finland, France, Georgia, Germany, Greece, HongKong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Ukrain, UK
Trial
details: 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 15-200mg/g) will be randomised into the study.The 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. (NCT01243424)
Latest
news: * On July 31, 2013, Boehringer Ingelheim and Eli Lilly have announced enrollment of the first patient into a cardiovascular and renal outcomes trial for linagliptin (Trajenta®). The CARMELINA trial will investigate linagliptin on cardiovascular and renal microvascular outcomes in adults with Type 2 Diabetes at risk of cardiovascular and renal events.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.
