Study on Novel Insulin Formulation

In a recent study, researchers have reported that a novel insulin formulation given once weekly was as safe and effective as a conventional daily insulin product for type 2 diabetes. The study findings will be presented at ENDO 2021, the Endocrine Society's annual meeting, compared an investigational drug called basal insulin Fc (BIF) with insulin degludec, a commercially available long-lasting daily insulin, in patients with type 2 diabetes.

Guidelines recommend that patients with type 2 diabetes undergo treatment escalation with the initiation of insulin when the treatment target is not achieved. But, there are often delays in the initiation of insulin treatment and the fact that decreasing the insulin injections might facilitate the treatment acceptance, improve adherence, and potentially improve blood sugar control. To further study the action of once-weekly basal insulin effects, Juan Frias, M.D and his team conducted a phase 2 study to demonstrate the safety and efficacy of the once-weekly injections of BIF compared with insulin degludec (control).

It was a 32-week, phase 2, randomized clinical trial conducted in 399 patients with type 2 diabetes and by Eli Lilly and Company. The researchers randomly assigned the patients to receive one of three treatment groups:

• Once-weekly injections of BIF at one of two different dosing algorithms (with different goals for fasting blood sugar levels) or
• The standard once-daily injections of insulin degludec.

They determined that fasting blood sugar target for:

• Insulin BIF, one dosing patients receiving BIF as 140 milligrams per deciliter (mg/dL) and other at or below 120 mg/dL.
• Insulin degludec as 100 mg/dL or less.

Key Findings of the Study

Compared with insulin degludec, the researchers found that patients taking BIF achieved similar long-term blood glucose control, as measured by haemoglobin A1c.

At baseline, the average HbA1c was 8.1 per cent. At the end of the study, the researchers noted an improvement in A1c of 0.6 per cent for BIF and 0.7 per cent for insulin degludec.

They also noted that the BIF use resulted in significantly lower rates of hypoglycemia.

Frias said in a press release that BIF has "the potential of a flatter and more predictable action than the current daily basal insulins, which may have contributed to the lower rates of hypoglycemia."

Frais concluded, "These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy," He further added, "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."

For further information visit: The Endocrine Society