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New drug weekly as safe and efficacious as insulin daily — NRI diabetes trial

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

"These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy," said Dr Juan Frias, the study's principal investigator and the medical director of the National Research Institute in Los Angeles, California.

The reduced number of injections with weekly insulin may improve adherence to insulin therapy, which could result in better patient outcomes than for daily basal insulins, Frias said. 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, he added.

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 decilitre (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% at the beginning of the study and at the end of the study had an average improvement in A1c of 0.6% for BIF and 0.7% for insulin degludec, the data showed.

Additionally, BIF use resulted in significantly lower rates of hypoglycaemia, or low blood sugar (less than 70 mg/dL). Severe untreated hypoglycaemia 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 hypoglycaemia."

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.


Study details
Once Weekly Basal Insulin Fc (BIF) is Safe and Efficacious in Patients with Type 2 Diabetes Mellitus (T2DM) Previously Treated With Basal Insulin

Juan Pablo Frias, Jenny Chien, Qianyi Zhang, Emmanuel Chigutsa, William Landschulz, Paula Wullenweber, Axel Haupt, Christof Kazda

Presented at ENDO 2021 on 21 March 2021

Basal insulin Fc (BIF; LY3209590) is a novel, once-weekly, long-acting IgG Fc-fusion protein that is being assessed for the treatment of diabetes mellitus. The presented study evaluated the safety and efficacy of BIF compared to insulin degludec over 32 weeks in patients with T2DM previously treated with oral antidiabetic drugs and a basal insulin. The study design included 2 different dosing algorithms for BIF (BIF-A1 and BIF-A2) with two different fasting glucose (FG) targets of ≤140 mg/dL (BIF-A1) and ≤120 mg/dL (BIF-A2). Insulin degludec was titrated to a FG target of ≤100mg/dL using a modified Riddle treat-to-target algorithm. Study participants (N=399) were randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. The average age of participants was 60.2 years, baseline HbA1c was 8.1% and duration of diabetes 14.7 years. There were no statistically significant differences in demographics or baseline characteristics across the 3 treatment groups. Both BIF groups achieved non-inferiority (noninferiority margin = 0.4%) for the primary endpoint of HbA1c change from baseline to Week 32 with a mean±SE reduction for BIF-A1, BIF-A2 and insulin degludec of 0.6±0.1%, 0.6±0.1% and 0.7±0.1%, respectively. In line with the different fasting serum glucose (FSG) targets, insulin degludec achieved greater FSG lowering from baseline as compared to the BIF arms. Similarly, both BIF dosing groups showed significantly fewer hypoglycemic events compared to insulin degludec (all documented events as well as nocturnal events) when assessing events ≤70 mg/dL (3.9 mmol/L). Hypoglycemic events<54 mg/dL (3.0 mmol/L – all documented events as well as nocturnal events) were not significantly different between the three dosing groups. Two severe hypoglycemic events were reported in BIF-A2. The reported treatment-emergent adverse events and serious adverse events were balanced across the 3 treatment groups. Both BIF groups had a statistically significantly smaller increase in body weight compared to insulin degludec from baseline to Week 32. In summary, BIF, when administered weekly according to either dosing algorithm, was non-inferior to insulin degludec for glycemic control as measured by change in HbA1c after 32 weeks with a lower rate of documented and nocturnal
hypoglycemia ≤70 mg/dL and less weight gain. Additionally, no safety signals were detected. While higher FG targets were chosen in this first Phase 2 study with BIF, the safety and tolerability results allow assessment of lower target glucose ranges in future trials. The results from this study support continued
development of BIF as a once-weekly insulin treatment of diabetes mellitus.


The Endocrine Society material

ENDO 2021 study abstract

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