First oral GLP-1 drug semaglutide performs well in phase II trial
Semaglutide could be the first GLP-1 receptor agonist drug to be developed that can be taken orally.
Results from a phase II study shows that the drug is effective in reducing body weight and blood glucose levels.
GLP-1 receptor agonist drugs currently approved by the FDA include Byetta, Bydureon, Victoza, Tazeum and Trulicity. This class of medication has been around since 2005 and has been shown to be particularly effective at reducing body weight in addition to reducing blood glucose levels. One factor that links all of these drugs is that they must be injected.
In developing semaglutide, Danish firm Novo Nordisk aims to create a new way of taking the drug that would save people with type 2 diabetes from having to take injections.
The phase II clinical trial compared four different doses of oral semaglutide (2.5, 5, 10, 20 or 40 mg once-daily) and compared the effects at the different doses against injected semaglutide (1 mg) and against a placebo pill. 632 participants in total took part in the trial.
The results showed that reductions in body weight and blood glucose increased dose dependently; that is the higher the dose, the greater effect. The proportion of participants experiencing side effects was also greatest on the highest dose than on lower doses.
The highest dose of oral semaglutide produced similar results to injected semaglutide without showing any new or unexpected side effects.
Whilst the oral form of the drug removes the need to inject, it had to be taken 30 minutes before eating. The researchers note that this may not always be followed so well outside of clinical trials. Essentially, real world patients may not be as patient as those on the trial.
The next step of development will involve testing on a larger number of participants in phase III trials which will allow more comprehensive analysis of the safety of the drug.
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