Patients with type 2 diabetes (T2D) had similar glucose-lowering effect from once-weekly insulin icodec as with daily insulin glargine U100. These findings, from a randomized, double-blind, double-dummy, phase 2 trial, were published in The New England Journal of Medicine.
Investigators randomly assigned 247 patients with T2D in a 1:1 ratio to receive weekly subcutaneous icodec with a daily placebo (n=125) or daily subcutaneous glargine plus a weekly placebo (n=122) for 26 weeks. They started doses at 70 U for icodec and 10 U for glargine and adjusted doses weekly to achieve a prebreakfast blood glucose level of 70 mg/dL to 108 mg/dL. They assessed patients for glycated hemoglobin (HbA1c) up to 5 weeks after the study conclusion.
Participants were 56.3% men, with a mean age of 59.6±8.9 years, who had T2D for 9.7±7.4 years, an average body mass index of 31.3±4.6 kg/m2, and HbA1c of 8.02%±0.68%.
Among the icodec recipients, HbA1c decreased from 8.09%±0.7% to an average of 6.69% (mean change, -1.33 percentage points) at week 26, which was similar to the glargine group (7.96%±0.65% to 6.87%; mean change, -1.15 percentage points). The difference between the groups was not significant (mean difference, -0.18 percentage points; 95% CI, −0.38 to 0.02; P =.08).
The proportion of patients who had <7% HbA1c at week 26 was 72% among icodec and 68% among glargine recipients (odds ratio 1.2; 95% CI, 0.98-2.13). The proportion of patients who achieved HbA1c <6.5% was 49% and 39% among the icodec and glargine groups, respectively (odds ratio 1.47; 95% CI, 0.85-2.52).
At the study conclusion, patients in the icodec group had a greater decrease of the mean 9-point patient-measured blood glucose level (mean difference, -7.86; 95% CI, −14.1 to −1.62 mg/dL).
More than half of the icodec and glargine recipients reported adverse events (52% vs 50.8%, respectively). Just 2 and 3 patients in the icodec and glargine groups, respectively, reported serious events.
Researchers observed level 1 hypoglycemia alerts among 53.6% of patients treated with icodec and 37.7% of patients treated with glargine (rate ratio 2.42; 95% CI, 1.5-3.88). Level 2 (16%) and 3 (9.8%) hypoglycemic events were rare (rate ratio 1.09; 95% CI, 0.45-2.65).
This study was limited by its sample size. The number of patients randomly assigned to each cohort was not sufficient to detect significant differences between the treatments.
These data indicated a once-weekly insulin icodec therapy was able to lower glucose in a similar manner as once-daily glargine.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Rosenstock J, Bajaj HS, Jazež A, et al. Once-weekly insulin for type 2 diabetes without previous insulin treatment. N Engl J Med. 2020;383(22):2107-2116.