Icodec Insulin

iStock, JHVEPhoto The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively. Eli Lilly on Tuesday unveiled data from two late-stage studies, further building the case for its once-weekly insulin efsitora in patients with diabetes. The pharma presented its findings at the 2024 Annual Meeting of European Association for the Study of Diabetes. In QWINT-2 , Lilly tested efsitora in insulin-naïve type 2 diabetes patients versus daily insulin degludec. Results showed that the once-weekly injection could lower A1C by 1.34%, compared with the 1.26% reduction in degludec patients—an effect that was non-inferior, according to the company. A1C level at 52 weeks was 6.87% after efsitora treatment and 6.95% in degludec comparators. Efsitora continued to match degludec in patients who were and were not taking GLP-1 receptor agonists, resulting in non-inferior reductions in A1C. QWINT-2 results also showed that patients treated with the weekly insulin spent 45 minutes more in time in range per day versus degludec, a key secondary endpoint. Efsitora’s safety pro similar to daily insulin, resulting in severe hypoglycemic episodes, versus six in the degludec arm. Time in hypoglycemia was not increased. “With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora,” Jeff Emmick, Lilly’s senior vice president of product development, said in a statement. The QWINT-2 readout adds to growing evidence supporting efsitora in type 2 diabetes. Last week, Lilly also posted data drops from QWINT-1 and QWINT-3, demonstrating that the once-weekly efsitora could match daily injections in patients who were insulin-naïve and in those who were switching to a weekly schedule from daily basal insulin. Lilly is also positioning efsitora as a potential once-weekly treatment for type 1 diabetes. At the EASD Annual Meeting, the pharma also revealed findings from the Phase III QWINT-5 study, which established the non-inferiority of efsitora versus daily degludec injections. At week 26, patients treated with efsitora saw a 0.53% drop in A1C, versus the 0.59% reduction in degludec comparators. A1C levels at this time point was 7.37% and 7.39% in the respective treatment arms. Efsitora also matched daily degluec in terms of the percent of time spent in range in the four-week period leading up to the 26-week follow-up. The rate of patients-reported clinically significant or severe hypoglycemic episodes was slightly higher in patients treated with efsitora, though the duration of hypoglycemia was comparable between treatments. Severe hypoglycemic events per patient-year of exposure were also slightly more frequent in the efsitora group. Findings from the QWINT program could help put Lilly ahead of Novo Nordisk, which failed to win the FDA’s approval for its once-weekly basal insulin icodec in July 2024. The regulator pointed to manufacturing issues and raised concerns about icodec’s benefit/risk pro type 1 diabetes.

Bagsværd, Denmark, 6 September 2024 – Novo Nordisk today announced the presentation of 21 abstracts (7 oral and 14 short oral presentations) at the upcoming 60 th Annual Meeting of the European Association for the Study of Diabetes (EASD), which will take place from 9 to 13 September 2024 in Madrid, Spain. In addition to the abstracts, data will also be presented in dedicated scientific symposia. These include results from the COMBINE clinical programme with IcoSema, a combination of once-weekly basal insulin icodec and once-weekly semaglutide, in people with type 2 diabetes, the FLOW trial evaluating semaglutide 1.0 mg on kidney outcomes in people with type 2 diabetes and chronic kidney disease, and amylin treatment for metabolic disease. “Cardiometabolic conditions like diabetes, obesity, cardiovascular and kidney disease, all result from closely interlinked underlying risk factors and are among the most significant health challenges society faces today. Tailored treatment options that aim to holistically address these conditions are therefore needed,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “At EASD this year, we are showcasing new data from across our diabetes, obesity, cardiovascular and renal pipeline and portfolio, where we continue to push boundaries with the goal of advancing treatments in order to help more patients.” Summary of presentations Accepted data at the 60 th annual meeting of the EASD include the following oral and short oral presentations. Accepted abstracts include preliminary data that may be subject to change in final published manuscripts. Dates and times of the presentations and the abstracts can be found on the EASD website . EASD scientific symposia EASD oral and short oral presentations Diabetes Awiqli ® (once-weekly basal insulin icodec) Ozempic ® (once-weekly semaglutide 1.0 mg) Non-product Obesity Wegovy ® (once-weekly semaglutide 2.4 mg) Saxenda ® (once-daily liraglutide 3.0 mg) Oral amycretin CagriSema Digital Health About Awiqli ® (once-weekly basal insulin icodec) Awiqli ® (once-weekly insulin icodec) is a novel once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. In the EU, Awiqli ® is indicated for the treatment of diabetes mellitus in adults. About Ozempic ® (semaglutide 1.0 mg) In the EU, Ozempic ® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes. About Wegovy ® (semaglutide 2.4 mg) In the EU, Wegovy ® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m 2 or greater (obesity), or adults with a BMI of 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy ® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. About Saxenda ® (liraglutide 3.0 mg) In Europe, Saxenda ® is indicated along with diet and increased physical activity for weight management in adults with a BMI of 30 kg/m 2 or greater (obesity), or adults with a BMI of 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Saxenda ® is also indicated for adolescents from 12 years of age with obesity (BMI of 30 kg/m 2 or more) who weigh more than 60 kg. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 69,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information