“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, Calif.
The 32-week clinical trial was conducted in 399 patients and sponsored by Eli Lilly and Company. All patients had type 2 diabetes and were previous users of basal insulin combined with oral antidiabetic medications.
The patients received random assignments to one of three treatment groups: once-weekly injections of BIF at one of two different dosing algorithms (with different goals for fasting blood glucose levels) or the standard once-daily injections of insulin degludec.
One fasting glucose target for patients receiving BIF was 140 milligrams per deciliter (mg/dL) or less, and the other was at or below 120 mg/dL. The fasting glucose target for insulin degludec was 100 mg/dL or less.
Compared with insulin degludec, patients taking BIF achieved similar long-term blood glucose control, as measured by hemoglobin A1c, the researchers reported. Study participants had an average A1c of 8.1 percent at the beginning of the study and at the end of the study had an average improvement in A1c of 0.6 percent for BIF and 0.7 percent for insulin degludec, the data showed.
Additionally, BIF use resulted in significantly lower rates of hypoglycemia, or low blood sugar (less than 70 mg/dL). Severe untreated hypoglycemia 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 the current daily basal insulins, which may have contributed to the lower rates of hypoglycemia.”
Regarding safety, BIF had a generally comparable adverse event profile to that of insulin degludec, he said.
“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.