Oral GLP-1 diabetes drug clears phase II trials
Novo Nordisk, the manufacturer of Victoza and a number of insulin drugs, has passed Phase II of trials for an oral version of a new GLP-1 agonist drug.
The drug, OG217SC, is the name for the oral version of semaglutide. The injected form of the drug is taken once weekly which therefore has an advantage over Novo’s Victoza which needs to be taken daily.
Whilst the oral form of the drug performed well at high doses, this was accompanied by a greater level of side effects.
Within the Phase II trials, the oral drug was trialled, at a number of doses, against injected semaglutide and placebo. The doses of the oral form of semaglutide varied from 2.5mg up to 40mg. The injected dose was lower at 1mg. The doses were compared, 600 patients with type 2 diabetes and mean A1c level of 7.9%, over a 26 week (6 month) period.
Phase II trial results
The different doses brought the following reductions in HbA1c:
- 2.5mg oral dose: 0.7% improvement in A1c
- 40mg oral dose: 1.9% improvement in A1c
- 1 mg injected dose: 1.9% improvement in A1c
- Placebo: 0.3% improvement in A1c
Weight loss was also reviewed and a similar level of weight loss, of around 6.5kg, was associated with the 1mg injected dose and the 40mg oral dose. By comparison, those on placebo experienced a 1kg weight loss.
Side effects of oral semaglutide
Whilst the higher dose of semaglutide performed as well as the injected form, there was a greater rate of side effects, such as nausea and vomiting, which could lead to the oral form being harder to tolerate despite not requiring injections.
Despite the greater level of side effects associated with the higher dose oral form, OG217SC was regarded as safe in terms of its side effects. The study also noted that the side effects diminished over time.
In addition to developing an oral form of a GLP-1 receptor agonist drug, Novo Nordisk is also developing an oral form of insulin. The success of OG217SC holds a certain amount of promise that Novo Nordisk may have success in delivering insulin in tablet form.
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