麻豆传媒

NEW ORLEANS -- An investigational insulin glargine known as MK-1293 proved non-inferior to the standard formulation sold as Lantus in change of average blood glucose from baseline in two phase III trials, a researcher reported here.

The biosimilar insulin pen from Merck met its primary and secondary end points in the 24-week trials, one of which was for type 1 diabetics and the other for type 2 diabetics, according to , at Newcastle University in England.

Home presented findings from the type 1 diabetes study at an oral session here at the annual meeting of the American Diabetes Association; the other study was reported at a poster presentation here.

MK-1293 is nearly identical to Sanofi's Lantus, with the same amino acid sequence, the same E. coli production cell, and the same pharmaceutical formulation, said Home.

In the first trial, about 500 patients with type 1 diabetes were randomized to either MK-1293 or to Lantus; the least-squares mean difference in A1c levels was 0.04% (95% CI -0.11 to 0.19).

Secondary outcomes included safety and tolerability, insulin dose dose requirements including meal-insulin use, fasting plasma glucose, a seven-point measure of plasma glucose, and proportion of participants reaching an HbA1c goal. There were no significant differences between groups in those measures, said Home.

All patients in the type 1 diabetes trial were adults, with an average age of 42, and were taking basal and prandial insulin at baseline; all had HbA1c levels of ≤11%. The average time with the condition was about 21 years, and about 70% of patients had previously taken Lantus. The authors also examined anti-insulin antibody development, which was also similar between groups.

All patients in the second trial had type 2 diabetes that wasn't adequately controlled on diet and exercise alone, and here too, MK-1293 met its primary endpoint by demonstrating non-inferiority to Lantus, with a least-squares mean difference in A1c of 0.03% (95% CI -0.12 to 0.18).

The dosage was similar between the groups in the study, which included more than 500 patients. The investigational insulin was similar to Lantus in its overall safety profile and its effects on body weight, anti-insulin antibody development, self-measured plasma glucose, and hypoglycemia risk.

Home guessed that the pen cartridge could be available next year. But the manner in which the FDA required HbA1c equivalency is "completely invalid" and that the regulators "certainly don't understand type 1 diabetes," Home asserted in an interview with 麻豆传媒.

"I think the emphasis that regulators give to HbA1c is inappropriate," he added. There are issues with how glucose is measured, which is generally self-monitored in the studies, but then the regulators won't look at self-monitored glucose, he said.

"The FDA needs to get a bit more modern and recognize that what is important to people with type 1 diabetes is not just HbA1c and long-term complications, but hypoglycemia as well," he said. "Really their job is to look after the consumer, and they've not switched on to that."

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