Weekly basal insulin shows comparable efficacy to daily insulin in type 2 diabetes

April 9, 2021 0 By FM

A new once-weekly insulin injection showed similar efficacy and safety and a lower rate of low blood sugar episodes when compared with a daily insulin, according to a phase 2 clinical trial.

The study results, presented at the Endocrine Society’s annual meeting ENDO 2021, compared an investigational drug called basal insulin Fc (BIF) with a commercially available daily insulin degludec, in patients with type 2 diabetes.

BIF is a long-acting IgG Fc-fusion protein. The current study was designed to assess the novel agent against daily insulin in a parallel arm trial in patients with diabetes previously treated with oral antidiabetic agents and basal insulin. The 32-week clinical trial included 399 patients with type 2 diabetes. The trial included 2 different dosing algorithms with 2 different fasting glucose targets (140 mg/dL or less and 120 mg/dL or less) compared against insulin degludec with a fasting glucose target of 100 mg/dL or less.

Results suggested that patients receiving basal insulin Fc (BIF) had a mean HbA1c improvement of 0.6% and these patients were able to achieve similar long-term blood glucose control to those receiving insulin degludec. Additionally, BIF use resulted in significantly lower rates of hypoglycemia, or low blood sugar (less than 70 mg/dL).

Safety analyses indicated hypoglycemic events were not significantly different between the study arms. Investigators also noted treatment-related adverse events and serious adverse events were balanced across the study arms.

Severe untreated hypoglycemia is a dangerous complication that can cause seizures, loss of consciousness and death. The reduced number of injections with the new weekly insulin may improve adherence to insulin therapy, which could result in better patient outcomes than for daily basal insulins.

“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, M.D., the study’s principal investigator and the medical director of the National Research Institute in Los Angeles, California.

Once-weekly dosing also may increase the willingness of patients with type 2 diabetes to start insulin therapy when oral medication alone no longer gives adequate blood glucose control.

“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,” Frias said.