ENDO 2021: An investigational once-weekly insulin formulation was found as effective as daily basal insulin injection for glucose control with lower rates of hypoglycemia and less weight gain.
A once-weekly basal insulin formulation was found to be as effective as daily insulin injection and was associated with a lower rate of documented and nocturnal hypoglycemia in a study presented at ENDO 2021, the Endocrine Society’s annual meeting.
The investigational drug, called basal insulin Fc (BIF) ) is a novel, once-weekly, long-acting IgG Fc-fusion protein, also demonstrated less weight gain when compared to once-daily insulin degludec, over the 32-week-long study.
“These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy,” said Juan Frias, MD, the study’s principal investigator and the medical director of the National Research Institute in Los Angeles, Calif, in an Endocrine Society press release.
Frias also noted that the once-weekly vs daily injection regimen may improve adherence with insulin therapy and so improve patient outcomes. The once-weekly injection could also reduce patient reluctance to initiate insulin therapy when oral medications are no longer adequate to maintain glucose control, he added.
Frias and colleagues evaluated the safety and efficacy of BIF vs insulin degludec over 32 weeks in patients with type 2 diabetes (T2D) previously treated with oral antidiabetes drugs and a basal insulin. Two different dosing algorithms for BIF were evaluated with 2 different fasting glucose (FG) targets: BIF-A1: ≤140 mg/dL and BIF-A2: ≤120 mg/dL.
Using a modified Riddle treat-to-target algorithm, insulin degludec was titrated to a FG target of ≤100 mg/dL.
Investigators randomized 399 participants in a 1:1:1 ratio to 1 of the 3 treatment groups. Mean age of participants was 60.2 years; baseline A1c, 8.1%; and diabetes duration, 14.7 years. Demographics and baseline characteristics were similar across the 3 groups.
Frias et al reported noninferiority for both BIF groups vs insulin degludec (margin = 0.4%) for the primary endpoint of change in A1c from baseline to week 32. Mean +/-SE reductions for the 3 groups were:
As anticipated, given the different FSG targets, FSG lowering from baseline was greater insulin degludec vs both BIF arms. Likewise, when assessing hypoglycemic events ≤70 mg/dL there were significantly fewer in both BIF arms vs insulin degludec. This includes all documented events as well as nocturnal events. There was no statistically significant difference observed among the 3 groups for more severe hypoglycemic events (<54 mg/dL).
Observed increases in body weight from baseline to week 32 were smaller in the BIF groups than in the insulin degludec group.
The study authors reported that treatment-emergent and serious adverse events were balanced across the 3 treatment groups.
Summarizing the findings, the authors write that when administered once a week and following either dosing algorithm studied, BIF was noninferior to insulin degludec for glycemic control as measured by change in A1c after 32 weeks of treatment. Rates of hypoglycemia <70 mg/dL and participant weight gain were lower in both investigational groups. No safety signals were detected.
The also note that the safety and tolerability results from this first phase 2 study will allow assessment of lower target glucose ranges going forward.
“Based on our promising data, further research with BIF has been initiated in patients with type 1 diabetes and other type 2 diabetes patient populations,” concluded Frias in the Endcorine Society statement.
Reference: Frias JP, Chien J, Zhang Q, et al. Once Weekly Basal Insulin Fc (BIF) is Safe and Efficacious in Patients with Type 2 Diabetes Mellitus (T2DM) Previously Treated With Basal Insulin. Presented at ENDO 2021, March 20-23, 2021.
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