Despite the long history of using insulin for the treatment of diabetes mellitus, the form of its administration has not undergone significant changes, and the drug, as before, is available only in injectable form.
On the one hand, the injection route of administration is an advantage, since it ensures the rapid entry of drugs into the systemic circulation and, therefore, quick onset of the effect.
On the other hand, patients who require daily systemic insulin injections experience inconvenience.
Find out in the article on estet-portal.com which diabetes management strategies will be the most relevant in the near future, and how this may affect approaches to the treatment of this disease.
- Difficulties in developing non-injectable insulin for the treatment of diabetes
- Results of a trial of oral insulin for the treatment of diabetes
- Prospects for the use of research results in the treatment of diabetesa
Difficulties in the development of non-injectable forms of insulin for the treatment of diabetes
The oral form of insulin for the treatment of diabetes has long attracted the attention of pharmacologists, but this task seemed impossible for a long time.
The main obstacle was stomach acid, which breaks down the protein before it can be absorbed into the intestinal wall.
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However, pharmaceutical company Oramed Pharmaceuticals, which specializes in the creation of oral forms of drugs available not only in injectable form, announced the creation of a new drug that has pH-neutral shell and has an increased ability to penetrate the intestinal membrane into the bloodstream.
This drug may be the first commercially available oral insulin for the treatment ofdiabetes.
Drug therapy for diabetic complications
Results from a trial of oral insulin for the treatment of diabetes
The results of the study show statistically significant data on the effectiveness of the drug.
Intestinal absorption of the drug allows insulin to be delivered directly to the liver, mimicking its natural transport in the body.
The result is more physiological insulin replacement, resulting in effective diabetes management with a lower risk of hypoglycemia.
In a multicentre, double-blind, placebo-controlled, randomized study performed by Oramed Pharmaceuticals, 269 patients with type 2 diabetes were included.
Patients were randomized into three groups, each of which formed a placebo control group.
In the treatment groups, study participants received insulin therapy at doses of 32 mg/day (1 dose), 64 mg/day (2 doses), and 96 mg/day (3 doses).
The primary endpoint of the study was decrease in glycated hemoglobin before week 12 of therapy.
In the subgroups that took insulin one and twice a day, there was a significant decrease in glycosylated hemoglobin compared with placebo (by 0.54 and 0.53% among the groups patients respectively).
There was no increase in the incidence of serious adverse events.
Glycemic rates were comparable between the active treatment and placebo groups.
In addition, the use of insulin orally did not lead to an increase in body weightla.
Modern therapy for type 2 diabetes
Perspectives of using the results of the study in the treatment of diabetes
Thus, the results of the presented study demonstrated the effectiveness and safety of oral insulin.
Company plans to continue clinical trials − Testing the drug at low doses, and if approved by the US Food and Drug Administration, a phase III study.
Scientists believe that the good safety profile of the drug is due to the fact that, absorbed in the intestines, insulin enters the liver, which is similar to the natural transportation of insulin in the body.
Therefore, the oral form of insulin may be even more physiological than the injectable, which will contribute to the high efficacy and safety of the drug for the treatment of diabetes.
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However, to confirm this assumption, it is necessary to perform specially designed large prospective studies.
These results show that this drug − it is a safe and effective form of insulin designed to improve disease control for the millions of people living with diabetes.
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