![]() ![]() Insulin icodec (proposed international nonproprietary name) is a basal insulin analogue administered once weekly that is in development for the treatment of patients with diabetes. 5 Therefore, reducing the number of injections could potentially increase acceptance of and adherence to insulin treatment among patients with type 2 diabetes, 6 thereby potentially improving glycemic control. 3,4 Previous data have indicated that patients with type 2 diabetes would generally prefer fewer injections and greater flexibility than is typical of the current once-daily treatment options. 1,2 Despite these recommendations, clinical inertia is highly prevalent in the management of type 2 diabetes, with the longest delays reported for insulin initiation (median time from initiation of treatment with one or more oral antidiabetic drugs to initiation of insulin treatment, 1.2 to 4.9 years). (Funded by Novo Nordisk NN1436-4383 number, NCT03751657.) IntroductionĮvolving guidelines for standards of care from the American Diabetes Association and the European Association for the Study of Diabetes recommend treatment escalation when individualized glycemic targets are not reached in patients with type 2 diabetes. Once-weekly treatment with insulin icodec had glucose-lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes. Most adverse events were mild, and no serious events were deemed to be related to the trial medications. There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low. ![]() The observed rates of hypoglycemia with severity of level 2 (blood glucose level, <54 mg per deciliter) or level 3 (severe cognitive impairment) were low (icodec group, 0.53 events per patient-year glargine group, 0.46 events per patient-year estimated rate ratio, 1.09 95% CI, 0.45 to 2.65). The estimated mean change from baseline in the glycated hemoglobin level was −1.33 percentage points in the icodec group and −1.15 percentage points in the glargine group, to estimated means of 6.69% and 6.87%, respectively, at week 26 the estimated between-group difference in the change from baseline was −0.18 percentage points (95% CI, –0.38 to 0.02, P=0.08). Baseline characteristics were similar in the two groups the mean baseline glycated hemoglobin level was 8.09% in the icodec group and 7.96% in the glargine group. ResultsĪ total of 247 participants were randomly assigned (1:1) to receive icodec or glargine. Safety end points, including episodes of hypoglycemia and insulin-related adverse events, were also evaluated. The primary end point was the change in glycated hemoglobin level from baseline to week 26. We conducted a 26-week, randomized, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec as compared with once-daily insulin glargine U100 in patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes. It is thought that a reduction in the frequency of basal insulin injections might facilitate treatment acceptance and adherence among patients with type 2 diabetes. The most trusted, influential source of new medical knowledge and clinical best practices in the world. Information and tools for librarians about site license offerings. Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. ![]() NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. ![]()
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