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Once-weekly insulin is a promising treatment option

Presented by
Dr Julio Rosenstock, University of Texas Southwestern, USA
EASD 2020
Phase 2
The once-weekly basal insulin analogue, icodec, showed comparable efficacy and safety to once-daily insulin glargine U100 in a phase 2 study (NCT03751657). Patients with type 2 diabetes who need basal insulin could potentially have a simpler, once-weekly treatment regimen without compromising blood sugar control and safety.

The investigational drug, insulin icodec, is a long-acting basal insulin analogue with a half-life of approximately 1 week. After injection, insulin icodec binds strongly but reversibly to albumin, resulting in a slow and steady release of active icodec that lowers blood sugar throughout the week. As it is a concentrated formulation, icodec’s injection volume is equivalent to that of daily glargine U100.

Dr Julio Rosenstock (University of Texas Southwestern, USA) and colleagues conducted a 26-week, randomised, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec 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 (HbA1c, 7.0-9.5%) by metformin with or without a dipeptidyl peptidase-4 inhibitor [1]. The results were published in the New England Journal of Medicine as well [2]. The primary endpoint of the study was a change in HbA1c from baseline to week 26. Safety, including hypoglycaemia and insulin-related adverse events, was also evaluated.

A total of 247 participants were randomly assigned to receive icodec (n=125) or glargine (n=122). Baseline characteristics were similar between the 2 arms. The results showed that the mean change from baseline in the HbA1c level was similar between the 2 arms (-1.33% for icodec vs -1.15% for glargine, P=0.08). The secondary endpoint, change in fasting plasma glucose level from baseline to week 26, decreased by 57.74 mg/dL and 53.86 mg/dL for the icodec and glargine groups, respectively (difference -3.9; 95% CI -11.9 to 4.2). Regarding hypoglycaemia, the icodec group had 0.53 events per patient-year, and the glargine group 0.46 events per patient-year (estimated rate ratio 1.09; 95% CI 0.45 to 2.65). Insulin-related adverse events did not differ between the groups, and the rates of hypersensitivity and injection-site reactions were both low. Overall, most adverse reactions were mild, and no serious events related to the trial drugs were reported.

  1. Rosenstock J, et al. Once-weekly basal insulin icodec offers comparable efficacy and safety vs. once-daily insulin glargine U100 in insulin naïve patients with type 2 diabetes inadequately controls on OADs. EASD 2020. Abstract #56.
  2. Rosenstock J, et al. N Engl J Med. 2020 Nov 26;383(22):2107-2116.

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