Second weekly insulin shows phase 2 promise for type 2 diabetes
medwireNews: A novel weekly insulin achieves similar glycemic control to insulin degludec at a higher fasting glucose target, report the investigators at the virtual ENDO 2021 meeting.
The first weekly insulin to report phase 2 findings – insulin icodec – achieved equivalent glycemic control to daily insulin glargine in people with type 2 diabetes.
The latest weekly insulin – basal insulin Fc (BIF) – comprises a single-chain insulin fused to a human immunoglobulin G Fc domain.
Presenter Juan Frias (National Research Institute, Los Angeles, California, USA) noted that in phase 1 research, BIF achieved a flatter peak-to-trough concentration than daily basal insulin over the course of a week, which he said “could result in more consistent and more predictable glycemic control, potentially reducing the risk of hypoglycemia.”
This phase 2 trial involved 399 people with insulin-dependent type 2 diabetes (excluding use of prandial insulin) and glycated hemoglobin (HbA1c) levels between 6.5% and 10.0% (48 to 86 mmol/mol). They were an average age of 60.2 years, with an average diabetes duration of 14.7 years, HbA1c level of 8.1% (65 mmol/mol), and BMI of 32.2 kg/m2.
The study participants were randomly assigned to receive BIF for 32 weeks, titrated to a fasting glucose target of either 120 or 140 mg/dL (6.7 or 7.8 mmol/L), or daily insulin degludec to a target of 100 mg/dL (5.6 mmol/L).
Frias explained that the more relaxed treatment targets with BIF were for safety reasons, given “this was the first study of this weekly insulin in a broad patient population, and [we] really wanted to have the utmost safety with respect to the titration.”
Despite the looser titration targets, BIF was statistically noninferior to degludec for the primary outcome of HbA1c change between baseline and week 32. Specifically, HbA1c fell by an average of 0.57% and 0.58% in people treated with BIF to a target of 120 and 140 mg/dL, respectively, and by 0.66% in the degludec group.
Average fasting blood glucose level was, however, significantly higher in the two BIF groups than the degludec group, in line with the treatment targets.
Nonetheless, more participants given BIF than degludec achieved HbA1c below 7.0% (53 mmol/mol) without nocturnal hypoglycemia (<54 mg/dL, 3.0 mmol/L), at 23–27% versus 19%.
Rates of documented and nocturnal hypoglycemia were significantly lower with BIF than degludec, and rates of daytime hypoglycemia were numerically lower. Non-documented hypoglycemia was ascertained via blinded continuous glucose monitors worn by the participants.
There was a low rate of anti-drug antibodies, Frias noted, with these appearing in 1.5–2.3% of the BIF groups and 0.9% of the degludec group.
Frias said that the phase 2 study program will now adopt a fasting glucose titration target of 100 mg/dL, and will include a broad range of people with diabetes, including type 1 diabetes.
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