ABOUT CAROLINA (NCT01243424) CAROLINA and CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor across a broad range of patients with type 2 diabetes. CAROLINA assessed the long-term CV safety profile of linagliptin versus glimepiride in patients with early type 2 diabetes at increased CV risk. Diab Vasc Dis Res . Generic Trade Name Trial Sitagliptin Januvia TECOS Saxagliptin Onglyza SAVOR-TIMI 53 Alogliptin Nesina EXAMINE Linagliptin Tradjenta CARMELINA DPP4 Inhibitors 7. Indeed, individuals with established CVD were usually excluded. In presenting findings from CARMELINA, a randomized controlled CV outcomes trial enrolling 6,979 adults across 605 centers in 27 countries, … Description: The goal of the trial was to evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin compared with the sulfonylurea glimepiride among patients with type 2 diabetes and elevated cardiovascular risk. The CREDENCE primary findings, published in April this year, showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin significantly reduced the risk for renal failure and cardiovascular disease in people with type 2 diabetes and chronic kidney disease. While CARMELINA is the first CVOT to provide evidence in a majority population with prevalent renal risk, further studies with DPP-4 inhibitors would be welcome, and results are expected shortly from the CAROLINA CVOT, which will compare linagliptin with a sulfonylurea as an active comparator . 2015;12(3):164-174. doi: 10.1177/1479164115570301 PubMed Google Scholar Crossref In brief, CARMELINA was a multicenter, international, randomized, double-blind study in patients with type 2 diabetes at high cardiorenal risk. 2 and 3 randomized clinical trials. Update 06-12-2019 | CARMELINA findings confirmed in highest CV risk subgroups. Thus, these studies had low CV event rates, and the events that did … Effect of linagliptin vs glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes: the CAROLINA Randomized Clinical Trial. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial JAMA. Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Nonstatins, Heart Failure and Cardiac Biomarkers, Smoking, Keywords: Blood Pressure, Cholesterol, LDL, Diabetes Mellitus, Type 2, Dipeptidyl Peptidase 4, Dipeptidyl-Peptidase IV Inhibitors, Hypoglycemia, Metabolic Syndrome X, Metformin, Myocardial Infarction, Primary Prevention, Risk Factors, Smoking, Stroke, Sulfonylurea Compounds, Weight Gain. The researchers will present these results in full, along with an a… CARMELINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. Patients with type 2 diabetes and elevated cardiovascular risk were randomized to linagliptin 5 mg daily (n = 3,028) versus glimepiride 4 mg daily (n = 3,014). The CAROLINA® trial is a randomised, active comparator, double blind study to evaluate the cardiovascular safety of linagliptin versus glimepiride in patients with T2DM at elevated cardiovascular risk. 2019 Sep 19;322(12):1155-1166. doi: 10.1001/jama.2019.13772. Patients were randomised between 2010 and 2012 from approximately 600 trial centres in 43 different countries. The CREDENCE primary findings, published in April this year, showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin significantly reduced the risk for renal failure and cardiovascular disease in people with type 2 diabetes and chronic kidney disease. CAROLINA is the only active-comparator CV outcomes trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. Guidelines CARMELINA (CArdiovascular and Renal Microvascular outcomE study with LINAgliptin) is the first CV outcomes trial … This new data from CAROLINA, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA, expands the evidence and experience with Tradjenta, to provide healthcare professionals with confidence in the long-term safety profile across a broad range of patients with type 2 diabetes." The trial involved 6,033 adults with type 2 diabetes observed for a median duration of more than six years. Please enable JavaScript on your browser, so that you can use all features of this website. Options for a second-line agent include a sulfonylurea or a DPP-4 inhibitor. CARMELINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. CAROLINA ® and CARMELINA ® make up the two cardiovascular outcome trials for linagliptin, providing one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor. 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