Phase 2 clinical trial results show lower blood sugar and comparable safety
Date: March 21, 2021
Source: Endocrine Society
Summary:
According to a phase 2 clinical trial, once-weekly basal insulin injections showed similar efficacy and safety and lower rates of hypoglycemia than daily basal insulin. The results of the study compared an investigational drug called basal insulin Fc (BIF) with insulin degludec, a commercially available daily insulin, in patients with type 2 diabetes.

According to a phase 2 clinical trial, once-weekly basal insulin injections showed similar efficacy and safety and lower rates of hypoglycemia than daily basal insulin. The results of the study, to be presented at ENDO 2021, the Endocrine Society’s annual meeting, compared a research drug called basal Fc insulin (BIF) with insulin degludec, a commercially available daily insulin on the market in patients with type 2 diabetes.

“The results of this study demonstrate that BIF has promise as a basal insulin for every day,” said Juan Frias, MD, principal investigator of the study and medical director of the National Institutes of Research in Los Angeles, Calif. once a week and could be an advance in insulin therapy. .

Reducing the number of weekly insulin injections may improve adherence to insulin therapy, says Frias, which could lead to better outcomes for patients than daily basal insulin injections, says Frias. Once-weekly dosing may increase a patient’s willingness to start insulin treatment with type 2 diabetes when oral medications no longer provide adequate glycemic control, he added.

The 32-week clinical trial involved 399 patients and was sponsored by Eli Lilly. All patients had type 2 diabetes and had previously used basal insulin in combination with oral antidiabetic drugs.

Patients were randomly assigned to one of three treatment groups: once weekly BIF injections with one of two different quantification algorithms (with different targets for fasting glucose levels) or insulin degludec injections. standard once a day. One fasting blood glucose goal for patients receiving BIF is 140 milligrams per deciliter (mg/dL) or less, and the other is equal to or less than 120 mg/dL. The fasting blood sugar target for insulin degludec is 100 mg/dL or less.

Compared with insulin degludec, patients taking BIF achieved similar levels of long-term glycemic control, as measured by hemoglobin A1c, the researchers reported. Study participants had an average A1c of 8.1% at the start of the study and at the end of the study had an average A1c improvement of 0.6% for BIF and 0.7% for insulin degludec, respectively. data shows.

In addition, the use of BIF significantly reduced the incidence of hypoglycemia, or low blood sugar (less than 70 mg/dL). Severe hypoglycemia left untreated is a dangerous complication that can cause seizures, loss of consciousness, and death. Frias said BIF has “the potential of a flatter and more predictable action than current basal daily insulin, which may have contributed to the reduced incidence of hypoglycemia.”

In terms of safety, BIF has a side effect profile comparable to insulin degludec, he said.

“Based on our promising data, further studies with BIF were initiated in patients with type 1 diabetes and other groups of patients with type 2 diabetes,” Frias said.

Source: Materials provided by The Endocrine Society.

Original link: https://www.sciencedaily.com/releases/2021/03/210321215440.htm

Translator: Tran Phuong

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