What is insulin:
Insulin is produced in the so-called beta cells of the pancreas and acts as a blood sugar-lowering hormone. The transport of sugar (i.e. glucose) from the bloodstream into the human cells and the regulation of the fat and protein balance are among the vital tasks of insulin.
In the context of diabetes mellitus, either too little insulin is produced or it cannot work properly or sufficiently in the body, which is why the blood sugar level is greatly increased. If the former is the case, type 1 diabetes can result. This diabetes, which is caused by a lack of insulin, requires insulin therapy in order to absorb the hormone through external supply. In rare cases, type 2 diabetes also requires insulin treatment. If the hormone is not sufficiently effective in the body, a relative insulin deficiency may occur. It is usually possible to correct this with dietary changes, exercise or blood sugar-lowering tablets (also called antidiabetics). If these methods are not sufficient, these diabetics may be given insulin.
This synthetically produced insulin (also called an insulin analog) from the manufacturer Novo Nordisk has a half-life (i.e., time period after which half of the outgoing decreasing value is reached) of 196 hours (about 8 days). When injected, this hormone binds to a specific protein (albumin), which leads to a slow and constant release of the active substance. This allows the patient's own blood glucose levels to be lowered during this time.
Founded in 1923, Novo Nordisk is one of the leading global healthcare companies specializing in diabetes, obesity, and rare blood and endocrine disorders. Headquartered in Denmark, it produces 50% of the global insulin supply and delivers it to 30 million people worldwide.
Phase 2 study:
Published in the New England Journal of Medicine in September 2020, the double-blind, double-dummy, randomized Phase 2 study evaluated the efficacy and safety of once-weekly insulin icodec. During the 26-week trial, 247 study participants were administered either the new insulin or, for comparison, insulin glargine U100, which is administered daily. The participants had no previous long-term insulin treatment and their type 2 diabetes was monitored by measuring glycated haemoglobin levels (i.e. the molecule in red blood cells that carries oxygen). The primary endpoint was the change in this hemoglobin level from baseline to week 26. Also assessed were safety endpoints, hypoglycemia (also called hypoglycemia), and insulin-related adverse events.
Mean glycated hemoglobin level (also labeled HBA1c) at baseline was 8.09% in the insulin icodec group and 7.96% in the insulin glargine group. The estimated mean change in HBA1c level was -1.33% in the icodec group and -1.15% in the glargine group compared with the outgoing value. The estimated mean values were 6.69% in the Icodec group and 6.87% in the glargine group at the last week, respectively. Accordingly, the group difference was 0.18%, which was less significant.
According to the study, there was no difference between the study groups in adverse events due to insulin. In addition, injection site reactions were minimal.
Additionally, the manufacturer launched a new Phase 1 study on Oct. 16, 2020, which will investigate how insulin icodec is absorbed into the blood when administered by injection at various sites in patients with type 2 diabetes.
Treatment with insulin icodec had a glucose-lowering effect and safety, similar to insulin glargine U100, in patients with type 2 diabetes. A phase 3 trial has been announced and will continue to evaluate the efficacy of the one-week insulin. If the trial is successful and the insulin is approved, the leading manufacturer that funded the trial may make the compound available globally.
Julio Rosenstock, M.D., Harpreet S. Bajaj, M.D., M.P.H., Andrej Janež, M.D., Ph.D., Robert Silver, M.D., Kamilla Begtrup, M.Sc., Melissa V. Hansen, M.D., Ph.D., Ting Jia, M.D., Ph.D., and Ronald Goldenberg, M.D. (2020): Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. The New England Journal of Medicine, USA