Obesity and diabetes are very often associated and the treatment of these patients must include adequate measures to achieve a reduction in body weight.
Semaglutide is an antidiabetic drug used to treat type 2 diabetes. It acts like human glucagon-like peptide-1 increasing insulin secretion, thus inducing an increase in glucose metabolism. Semaglutide is packaged in a prefilled pen to be administered subcutaneously.
One of the main advantages of this drug, in comparison with other diabetes treatments, is its long duration of action, approximately 64 hours. For this reason, a single administration on a weekly basis is sufficient. The approved dose for the treatment of diabetes is 1 mg.
Semaglutide also appears to induce an increase in β cells in the pancreas. Moreover, it inhibits glucagon, a hormone that raises blood sugar.
Among the other actions of the drug there is a reduction in food intake. This effect seems to be induced by a reduction in appetite and a slowing of gastric transit. Thanks to these properties it seems able to help in reducing body weight in patients with diabetes.
A new research, recently published in The Lancet, showed that the administration of semaglutide, in adults with overweight or obesity and type 2 diabetes, resulted in a greater reduction in body weight than placebo. The drug was administered subcutaneously once a week.
This phase 3 study evaluated the efficacy and safety of semaglutide with a double-blind, double-dummy, three-arm experimental design: subcutaneous semaglutide 2,4 mg per week, semaglutide 1 mg per week and placebo.
To be included in the trial, patients needed to have a body mass index of at least 27 kg/m2, a glycated hemoglobin level of 7-10%, and a diagnosis of type 2 diabetes from at least 180 days.
Patients were recruited from 149 clinics spread across 12 countries in Europe, North America, South America, Middle East, South Africa and Asia.
The patients followed their treatment for 68 weeks, which was accompanied by a lifestyle intervention.
Coprimary endpoints were percentage change in bodyweight and achievement of weight reduction of at least 5% at 68 weeks for semaglutide 2,4 mg versus placebo. Safety was evaluated in all patients who received at least one dose of study drug.
From June 4 to November 14, 2018, 1,210 patients were randomly assigned to semaglutide 2.4 mg, semaglutide 1.0 mg or placebo and included in the intention-to-treat analysis.
The estimated change in mean body weight from baseline to week 68 was −9.6% with semaglutide 2.4 mg, compared with −3.4% with placebo. Therefore, the estimated difference for semaglutide 2.4 mg versus placebo was −6.2 percentage points.
At the end of the study, at week 68, a weight reduction of at least 5% was achieved in a greater number of patients treated with semaglutide 2.4 mg, compared to placebo.
Adverse events were more frequent with semaglutide 2.4 mg and 1.0 mg than with placebo.
Gastrointestinal adverse events, usually mild or moderate, were reported in 63.5% of patients treated with semaglutide 2.4 mg, 57.5% of those treated with semaglutide 1.0 mg and 34.3% of those included in the control group.
Semaglutide is approved for the control of type 2 diabetes, with gradually increasing doses, until the recommended dose of 1 mg per week is reached.
This new research, sponsored by Novo Nordisk A/S, seems to indicate that in adults with overweight or obesity and type 2 diabetes semaglutide, at a dose of 2.4 mg, once a week, is able to induce a significant reduction in body weight.
On the other hand, the side effects detected during the trial were not few, although in the control group they were also quite frequent.
Particularly, those usually expected are nausea and diarrhea, related to the effects of the drug on the gastrointestinal system. Other most reported adverse effects include vomiting, abdominal pain, cholelithiasis and a form of retinopathy.
All these adverse events could be considered sustainable to achieve optimal glycemic control, but are they also justified as a consequence of increased dose regimen to reduce body weight? Once again, the answer to this question probably lies in the physician’s overall clinical judgment, centered on the tailored evaluation of the single patient.
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