ADA 2020. An investigational once-weekly insulin proved comparable in safety and efficacy to traditional once-daily insulin glargine in findings presented at the ADA 80th Annual Virtual Scientific Sessions.
A novel once-weekly basal insulin analog demonstrated comparable efficacy and safety vs once-daily insulin glargine U100 (IGlar U100) in insulin-naïve type 2 diabetes (T2D) poorly controlled on oral antidiabetes drugs (OADs), according to research presented on Sunday, June 14, 2020, at the 80th Annual American Diabetes Association Virtual Scientific Sessions
In the 26-week, randomized, double-blind, double-dummy, treat-to-target, phase 2 trial, participants (n = 247) were randomized 1:1 to the investigational insulin icodec (icodec; n = 125) or to IGlar U100 (n = 122). At baseline, patients were inadequately controlled (A1c 7.0-9.5%) with metformin with or without a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Starting doses were icodec 70 U weekly and IGlar U100 10 U daily, with weekly titration to a pre-breakfast self-monitored blood glucose (SMBG) target of 70-108 mg/dL.
Baseline characteristics appeared similar in both groups; mean age was 59.6 years, diabetes duration 9.7 years, BMI 31.3 kg/m2 and fasting plasma glucose (FPG) 181 mg/dL. Mean baseline A1C was 8.1% for the icodec group and 8.0% for the IGlar U100 group.
The primary endpoint was change in A1c from baseline to week 26 and secondary endpoints included change in FPG from baseline to week 26 and hypoglycemic episodes.
At week 26, estimated mean A1c was 6.69% for icodec and 6.87% for IGlar U100 (estimated mean change from baseline: -1.33% and -1.15%-points, respectively).
There was no statistically significant treatment difference for change in A1c from baseline to week 26 (-0.18%, 95% CI, -0.38; 0.02).
Estimated mean FPG at week 26 was 123 mg/dL (icodec) and 127 mg/dL (IGlar U100).
Observed rates of level 2 (<54 mg/dL) + 3 (severe) hypoglycemia were low (60.55 and 52.36 events per 100 patient years of exposure for icodec and IGlar U100, respectively) and were comparable (p = 0.85).
There were no unexpected safety findings.
Insulin icodec is the first once-weekly insulin with similar glucose-lowering effects and safety profile to once-daily IGlar U100. Study authors note that icodec could improve treatment acceptance and facilitate T2D management in patients needing basal insulin.