The Boehringer Ingelheim and Lilly Alliance in Diabetes announces that the Carmelina®1 clinical trial (cardiovascular safety and microvascular renal outcome with linagliptin »), in patients with type 2 diabetes and high vascular risk, has fulfilled its main assessment criteria defined as timeUntil the appearance of cardiovascular death (CV), non-fatal myocardium infarction and non-fatal stroke (3-Point Mace), with suiting® (linagliptin) demonstrating similar CV security compared to placebo.
People with diabetes have a higher risk of cardiovascular disease and kidney disease.In spite of the recent advances in therapeutic alternatives, cardiovascular disease remains the main cause of death in people with diabetes and about two thirds of cases of chronic renal disease are attributable to metabolic disorders such as diabetes, obesity andarterial hypertension.
Waheed Jamal, MD, Corporate Vice President and Director of Cardiometabolic Medicine Boehringer Ingelheim indicates that "Carmelina® reinforces the long -term clinical security profile of linagliptin in adults with DM2, even in patients most vulnerable to vascular complications."And adds "this essay provides new important data for patients with high risk of developing heart and renal diseases, a population that has been infrarremed in other clinical trials of cardiovascular results in diabetes."
For his part, Jeff Emmick, MD, PHD, Vice President, Development of Products Lilly Diabetes says that “linagliptin has demonstrated cardiovascular safety in adults with type 2 diabetes and high cardiovascular risk, without the need to make dose adjustments and regardless of therenal function and this provides confidence as an effective and well tolerated treatment in adults with type 2 diabetes, with a simple dosage pattern ”
about Carmelina®
The complete results of the Carmelina® clinical trial (cardiovascular safety and renal microvascular results with linagliptin in patients with type 2 diabetes and high vascular risk) will be presented on October 4, 2018 at the 54th Annual Meeting of the European Association for the study of the study of the study of theDiabetes (EASD), which will be held in Berlin, Germany.
Carmelina® is a multinational, randomized, double -blind and placed clinical trial in which 6,979 adults with type 2 diabetes of more than 600 centers from 27 countries have participated, with an average duration of 2.2 years1.
Most patients also had kidney disease, an important risk factor for CV disease.The global linagliptin security profile in Carmelina®, including adults with kidney disease, was consistent with previous data and no new safety signals were observed.
The population included in the clinical trial corresponds to patients who do doctors in their daily practice.Compared to other clinical essays of cardiovascular safety recently published on the Dipeptidil peptidase4 (DPP-4) inhibitors in type 2 diabetes, the Carmelina® study includes a higher number of patients with altered renal function.