In a nutshell
This study compared the safety and effectiveness of oral semaglutide with liraglutide administered via subcutaneous (under the skin) injection in patients with type 2 diabetes (T2D). The authors concluded that both treatments were similarly safe and effective in these patients.
Glucagon-like-peptide-1 (GLP1) receptor agonists are a type of drug used in T2D. GLP1s currently used are only available via subcutaneous injection. These include liraglutide (Victoza) and semaglutide (Ozempic). Semaglutide has shown a greater impact on decreasing HbA1c (average blood glucose levels over the past 3 months) and body weight than some other drugs in the class.
An oral (by mouth) version of semaglutide is under development. The safety and effectiveness of oral semaglutide compared to injected liraglutide in patients with T2D remain under investigation.
Methods & findings
This study included, recruited 711 patients with T2D. All patients were treated with metformin (Glucophage; a glucose-lowering drug). Patients were assigned to one of three groups. Group 1 received a placebo (inactive tablet and subcutaneous injection). Group 2 received a semaglutide tablet and a placebo injection. Group 3 received a subcutaneous liraglutide injection and a placebo tablet. The study lasted for 52 weeks.
After 26 weeks, the average decrease in HbA1c levels was by 1.2% with oral semaglutide. This was compared to a decrease of 1.1% with injected liraglutide and by 0.2% with placebo. Oral semaglutide resulted in greater weight loss (by 4.4 kg) compared to both injected liraglutide (by 3.1 kg) and the placebo (by 0.5 kg) after 26 weeks.
Up to week 52, rescue medication (patients needing extra medication to control blood glucose levels) was needed by 7% of patients in group 2. This was compared to 6% in group 3 and 30% in group 1. Group 3 needed to stop the study earlier compared to group 2.
Side effects occurred in 80% of patients in group 2, 74% of group 3 and 67% of those in group 1. Group 2 had more common stomach and bowel-related side effects such as nausea and diarrhea. They were mild to moderate.
The bottom line
In summary, oral semaglutide was safe and had similar effectiveness to injected liraglutide in patients with T2D.
The fine print
This study was funded by Novo Nordisk, the manufacturer of both oral semaglutide and injected liraglutide.
Published By :
Lancet (London, England)
Original Title :
Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial.
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