Once-Weekly Basal Insulin Proves Noninferiority to Daily Degludec in Insulin-Naive Patients

Article

A phase 2 trial comparing once weekly basal insulin Fc against once daily insulin degludec, results of the study will help provide the basis for forthcoming phase 3 research examining the agent.

Juan Frias, MD | Courtesy: Velocity Clinical Research

Juan Frias, MD
Courtesy: Velocity Clinical Research

New research from a phase 2 trial suggest once-weekly basal insulin Fc achieved similar glycemic control as once-daily insulin degludec in patients with type 2 diabetes (T2D).1

Led by Juan Frias, MD, results of the study, which included 278 insulin-naive patients with T2D, indicate once-weekly basal insulin Fc demonstrated noninferior HbA1c change from baseline compared with once-daily insulin degludec during the 24-week trial.1

“An efficacious and safe once-weekly basal insulin treatment has the potential to overcome clinical inertia and support the initiation of insulin therapy at an appropriate time for insulin-naive patients with T2D,” wrote investigators.1 “Moreover, a basal insulin option that is simple to initiate, easy to titrate, convenient, and provides relevant glycemic improvement is essential for this patient population.”

The latest data related to once-weekly basal insulin Fc, the results of the current study add to the growing understanding of the agent’s potential. At the Endocrine Society 2021 annual meeting, Frias, who is the medical director and principal investigator of the National Research Institute, presented data from a phase 2 trial in people with T2D previously treated with basal insulin.2 In the parallel-arm trial, which compared 2 formulations of once-weekly basal insulin Fc against insulin degludec, results suggested both formulations achieved noninferiority (margin=.4%) for the endpoint of HbA1c change from baseline to week 32.2

In the current study, which was a randomized, parallel, open-label phase 2 trial, Frias and investigators sought to assess the safety and efficacy of basal insulin Fc in insulin-naive patients with T2D previously treated with oral antihyperglycemic medications. The trial randomized 278 individuals in a 1:1 ratio to once weekly basal insulin Fc or once daily insulin degludec, with both groups titrated to a fasting glucose of 80-100 mg/dL.1

The trial’s primary outcome of interest was HbA1 change form baseline to week 26, with a noninferiority margin of 0.4%. The trial included multiple secondary outcomes of interest, such as fasting blood glucose, 6-point glucose profiles, and rate of hypoglycemia.1

Upon analysis, results indicated basal insulin Fc demonstrated non inferiority for HbA1c change from baseline compared to once daily insulin degludec, with a treatment difference of 0.06% (90% confidence interval [CI], -0.11 to 0.24; P=.56). Further analysis demonstrated both treatment groups experienced significant reductions in fasting blood glucose from baseline, with a between-treatment difference for once weekly basal insulin Fc and once daily insulin degludec of 4.7 mg/dL (90% CI, 0.1 to 9.3; P=.09).1

Investigators pointed out the rate of level 2 hypoglycemia was low and not significantly difference between the treatments groups and no severe hypoglycemia was reported during the trial. Investigators also pointed out adverse events were balanced between both groups. However, results indicated there were 6 adverse events among the once weekly basal insulin Fc group identified using standard Medical Dictionary for Regulatory Activities query for hypersensitivity, whereas no such events were observed among the once daily insulin degludec group.1

“Data from this study will be used to develop a phase 3 dosing algorithm that is more consistent with commonly used approaches for daily basal insulin adjustment and less individualized. BIF is currently in phase 3 development, referred to as the Once Weekly Insulin Therapy (QWINT) program,” investigators added.1

References

  1. JM Bue-Valleskey, CM Kazda, C Ma, et al. Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Diabetes Care 2023; dc222396. https://doi.org/10.2337/dc22-2396
  2. Campbell P. Once-weekly basal insulin FC shows promise in phase 2 trial. HCPLive. https://www.endocrinologynetwork.com/view/once-weekly-basal-insulin-fc-shows-promise-in-phase-2-trial. Published April 1, 2021. Accessed March 23, 2023.

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