Onwards! Novo Nordisk's once-weekly insulin marches on after hitting goals in pair of phase 3 trials

Novo Nordisk has added more threads to the data tapestry it is weaving in support of the once-weekly insulin icodec, dropping positive top-line results from two phase 3a studies in its six-part ONWARDS program.

The Danish drugmaker posted data from ONWARDS 1, 2 and 6 earlier this year. All three studies hit their primary endpoints, raising hopes that insulin icodec can address some of the issues associated with the use of once-daily basal insulin analogs such as Novo’s own Tresiba. In theory, reducing the frequency of dosing could improve convenience, adherence, quality of life and, by extension, glycemic control.

Novo released top-line data from two more insulin icodec studies, ONWARDS 3 and 4, on Friday. Like the other ONWARDS trials, the two studies met their primary endpoints by achieving noninferiority to active controls. 

Tresiba was the control in ONWARDS 3, which enrolled 588 insulin-naïve people with Type 2 diabetes. After 26 weeks of treatment, hemoglobin A1c, a measure of blood sugar, had fallen 1.57% from a baseline of 8.5% in the insulin icodec cohort, compared to a 1.36% reduction in the control group. Novo saw no statistically significant difference in severe or clinically significant hypoglycemia, although the rate was numerically higher in the insulin icodec group. The firm said the drug appeared safe and well tolerated. 

ONWARDS 4 looked at basal-bolus treatment in people with Type 2 diabetes, pitting insulin icodec against insulin glargine, sold by Sanofi as Lantus. After 26 weeks, hemoglobin A1c had fallen 1.16% from a baseline of 8.3% in the insulin icodec cohort, compared to a 1.18% reduction in the control group. Again, Novo saw no statistically significant difference in severe or clinically significant hypoglycemia.

“We are very pleased to see that the results from ONWARDS 3 and 4 reinforce the potential of once-weekly insulin icodec to simplify basal insulin therapy for people with type 2 diabetes as an ideal starter insulin and as an attractive option in combination with mealtime insulin,” Martin Holst Lange, executive vice president for development at Novo, said in a statement.

Novo now has data from five of the six clinical trials in its phase 3 ONWARDS program. Top-line results from the remaining study, ONWARDS 5, are due by the end of the year.