Eli Lilly's Once-Weekly Basal Insulin Fc (BIF) Demonstrates Non-Inferior Glycemic Control and Lower Hypoglycemia Risk Compared to Daily Insulin Degludec in Phase 2 Trial

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According to a Phase 2 clinical trial (NCT03736785), a new once-weekly basal insulin injection demonstrated similar efficacy and safety, with a lower incidence of hypoglycemia, compared to once-daily basal insulin. These findings were presented at the 2021 Annual Meeting of the Endocrine Society (ENDO 2021). The study compared the therapeutic effects of an investigational drug known as basal insulin Fc (BIF, LY3209590) with those of a commercially available long-acting, once-daily basal insulin product, insulin degludec, in patients with type 2 diabetes.

Reducing the frequency of insulin injections to once weekly may improve adherence to insulin therapy, potentially yielding better outcomes than daily basal insulin injections. When oral medications alone are insufficient for glycemic control, a once-weekly regimen may also increase the willingness of patients with type 2 diabetes to initiate insulin therapy.

BIF (LY3209590) is an investigational once-weekly basal insulin product developed by Eli Lilly for the treatment of diabetes, including type 1 and type 2 diabetes. This drug is a large-molecule therapeutic that fuses engineered insulin to an Fc domain to provide a long-acting basal insulin formulation.

According to Eli Lilly’s pipeline information, BIF is currently in Phase II clinical development. A search of the ClinicalTrials.gov database shows that the drug is involved in a total of eight clinical trials, including five Phase I trials and three Phase II trials.

A 32-week Phase II clinical trial involving 399 patients was announced at this conference. All participants had type 2 diabetes and had previously been treated with basal insulin in combination with oral hypoglycemic agents.

In the study, these patients were randomly assigned to one of three treatment groups: once-weekly subcutaneous injection of BIF according to two different dosing algorithms (with different target fasting plasma glucose levels), or once-daily subcutaneous injection of standard insulin degludec. Among patients receiving BIF, one group had a target fasting plasma glucose level of ≤140 mg/dL, and the other had a target of ≤120 mg/dL. For patients receiving insulin degludec, the target fasting plasma glucose level was ≤100 mg/dL.

The study results showed that patients receiving BIF treatment achieved similar long-term glycemic control compared to those receiving insulin degludec, as indicated by hemoglobin A1c (HbA1c) measurements. Data showed that at the start of the study, the mean baseline HbA1c was 8.1%. By the end of the study, the mean HbA1c improvement was 0.6% in the BIF group and 0.7% in the insulin degludec group.

Furthermore, treatment with BIF significantly reduces the incidence of hypoglycemia (<70 mg/dL). In terms of safety, the adverse reaction profile of BIF is generally comparable to that of insulin degludec.

Severe, untreated hypoglycemia is a dangerous complication that can lead to seizures, loss of consciousness, and death. Juan Frias pointed out that BIF has the potential for “a flatter and more predictable profile compared with currently available once-daily basal insulins,” which may account for the reduced incidence of hypoglycemia.

Based on promising data, further studies have been initiated to evaluate the efficacy and safety of BIF in patients with type 1 diabetes (Phase II study, NCT04450407) and other patient populations with type 2 diabetes (Phase II study, NCT04450394).

Reference Source: Weekly insulin helps patients with type 2 diabetes achieve similar blood sugar control to daily insulin