Phase 2 clinical trials have shown that new weekly basal insulin injections have similar efficacy and safety, as well as a lower incidence of hypoglycemic episodes, compared to daily basal insulin. The results of the study, presented at ENDO 2021, the annual meeting of the Japan Endocrine Society, show that patients with type 2 diabetes are given an investigational drug called basal insulin Fc (BIF) and insulin degludec, a long-lasting daily insulin on the market. I compared.
“The results of these studies show that BIF is a promising weekly basal insulin and has the potential to advance insulin therapy,” said Principal Investigator of the Study, Los Angeles, CA. Dr. Juan Frias, MD, Medical Director of the National Institute, said. ..
Reducing the number of weekly insulin injections may improve compliance with insulin therapy, which may result in better patient outcomes than daily basal insulin, Frias said. Weekly administration may also motivate people with type 2 diabetes to start insulin therapy when oral medications alone do not provide adequate glycemic control, he added.
The 32-week clinical trial was conducted in 399 patients and was sponsored by Eli Lilly and Company. All patients have type 2 diabetes and were former users of basal insulin in combination with oral antidiabetic drugs.
Patients were randomly assigned to one of three treatment groups. A weekly injection of BIF with one of two different dosing algorithms (with different fasting blood glucose targets), or a standard once-daily injection of insulin degludec. One fasting blood glucose target for patients undergoing BIF was 140 milligrams (mg / dL) or less per deciliter, and the other was 120 mg / dL or less. The fasting blood glucose level of insulin degludec was less than 100 mg / dL.
Compared to insulin degludec, patients taking BIF achieved similar long-term glycemic control when measured with hemoglobin A1c, the researchers reported. Participants had a mean improvement in A1c of 8.1% at the beginning of the study, 0.6% in BIF and 0.7% in insulin degludec at the end of the study.
In addition, the use of BIF significantly reduced the incidence of hypoglycemia or reduced blood glucose levels (<70 mg / dL). Severe untreated hypoglycemia is a dangerous complication that can cause seizures, loss of consciousness, and death. "It has the potential for a flatter, more predictable effect than current daily basal insulin, which may contribute to a lower incidence of hypoglycemia," Frias said in a statement to BIF.
In terms of safety, he said, BIF had an adverse event profile similar to insulin degludec.
“Based on our promising data, further research by BIF has been initiated in patients with type 1 diabetes and other populations of type 2 diabetes,” Frias said.
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