Long-Term Insulin – Are These Studies Changing the Lives of Diabetics?

The modification of the human metabolic hormone from biotech production has brought many improvements for diabetics in recent decades: On the one hand, there are extremely fast and short-acting forms of insulin that diabetics can calculate the right dose while eating and then inject themselves.

However, for type 2 diabetics, the administration of long-acting insulins is often necessary in the later course of their disease. 24-hour insulin has been around here for a long time. Apparently, insulins that only need to be injected once a week should be approved soon.

Ultra Langzeit-Insulin Icodec
Recently, the annual convention of the American Diabetes Association (ADA Convention; June 22-26) was held in San Diego, California. Two large-scale approval studies for the ultra-long-term insulin Icodec were presented there. At the same time, the two clinical trials were published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa2303208) and in the Journal of the American Medical Association (JAMA; DOI:10.1001/jama.2023.11313).

In the study, published in the New England Journal of Medicine, Texas diabetologist Julio Rosenstock (Velocity Clinical Research) and his coauthors compared two groups of adults with type 2 diabetes. 492 patients each received the ultra-long-acting insulin once a week or a conventional insulin daily. long-acting insulin.

Similar effect of both insulins
The results favored the form of the metabolic hormone, which should only be administered once a week: over a period of 52 weeks, the level of sugar-laden red blood cells (HbA1c; medium-term meaningful parameter for blood sugar control) fell from an average of 8.5 to 6.93 percent. In the comparison group with daily insulin injections, a reduction was recorded from an average of 8.44 percent to 7.12 percent. Values ​​of 6.5 percent and below speak for good blood sugar control in diabetics.

While the patients taking ultra-long-acting insulin had blood sugar levels between 70 and 180 milligrams per deciliter of blood nearly 72 percent of the time, this proportion was significantly lower in the comparison group at nearly 67 percent. On the other hand, more episodes of low blood sugar (hypoglycaemia) were recorded in the weekly insulin group. This was not rated as questionable as they turned out to be small.

Half-life in the body of 196 hours
The new basic insulin has an extremely long half-life in the human body of 196 hours. The manufacturer, the Danish diabetes therapy pioneer company Novo Nordisk, has modified human insulin by changing three amino acid components and making other modifications in this way. On the one hand, insulin is broken down very slowly, on the other hand, after binding to albumin protein in the blood, it is released only slowly after injection under the skin.

An international study (92 centers in eleven countries) of the new insulin (published in JAMA) came to very similar results to those of Rosenstock and his co-authors. One group of 294 diabetics each received the new form of insulin once a week (with otherwise daily placebo injections) or daily 24-hour insulin for comparison. The reduction in HbA1c levels was almost identical to that in the other clinical study.

Again, the ultra-long-acting insulin was slightly better. However, more episodes of hypoglycaemia were also recorded with use, but these were extremely rare (less than one such episode per year on average).

New insulin submitted for approval
Novo Nordisk has already submitted the new insulin for approval in the US and Europe, as well as with the drug authorities of other countries. Type 2 diabetics can often avoid or delay drug treatment by changing their lifestyle, losing weight and getting plenty of exercise.

This is mostly followed by oral antidiabetics and also new injectable drugs (GLP-1 agonists, etc.) and/or drugs that promote the excretion of sugars via the kidneys. However, as the disease progresses, insulin may eventually become necessary.