Blood sugar control: Once weekly novel insulin shows promise in Diabetes
The researchers have found in a randomized, double-blind phase 2 trial that once-weekly treatment with basal insulin icodec had blood sugar lowering efficacy and a safety profile similar to those of once-daily insulin glargine.The results "suggest that once-weekly insulin has the potential to facilitate insulin management, providing clinical benefits and reducing the number of injections per year from 365 to 52."
The study has been published in the New England journal of Medicine.
Insulin icodec* is a novel basal insulin analog designed for single once-weekly (OW) subcutaneous injection. Earlier in a phase 2 clinical trial, adults with type 2 diabetes randomised to once-weekly investigational insulin icodec achieved similar blood sugar control and a similar safety profile compared with adults with type 2 diabetes randomised to once-daily insulin glargine U100.The results had been presented during the 80th Scientific Sessions of the American Diabetes Association.
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. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes.
The researchers 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.
The primary end point was the change in glycated hemoglobin level from baseline to week 26. Safety end points, including episodes of hypoglycemia and insulin-related adverse events, were also evaluated.
The investigators in a total of 247 participants randomly assigned (1:1) to receive icodec or glargine insulin. It was ensured that the 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.
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). The observed rates of hypoglycemia with severity of level 2 (blood glucose level, <54 mg per deciliter) or level 3 (severe cognitive dysfunction) 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).
It was observed that there was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low. Most adverse events were mild, and no serious events were deemed to be related to the trial medications.
The researchers concluded that once-weekly treatment with insulin icodec had blood sugar lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes.
ClinicalTrials.gov number, NCT03751657.)
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DOI: 10.1056/NEJMoa2022474
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