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PIONEER 8: Oral semaglutide reduces HbA1c, body weight as addition to insulin in type 2 diabetes
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Oral semaglutide was shown to be superior to placebo for lowering HbA1c and body weight among adults with type 2 diabetes already taking insulin with or without metformin, according to findings published in Diabetes Care.
“When added to insulin in the setting of inadequately controlled type 2 diabetes, oral semaglutide was superior to placebo at improving glycemic control and reducing body weight over 26 weeks, with significant differences also seen at 52 weeks, and with no increase in the risk of hypoglycemia,” Bernard Zinman, MD, a senior investigator at the Lunenfeld-Tanenbaum Research Institute of Mount Sinai Hospital, University of Toronto, and colleagues wrote. “Furthermore, the overall safety profile was consistent with that of other GLP-1 receptor agonists.”
As part of the PIONEER 8 trial, Zinman and colleagues randomly assigned a daily regimen of 3 mg oral semaglutide (Rybelsus, Novo Nordisk), 7 mg oral semaglutide, 14 mg oral semaglutide or placebo to 731 adults with type 2 diabetes who were already using insulin (mean age, 61 years; mean HbA1c, 8.2%; mean body weight, 85.9 kg; 46% women). The researchers assessed HbA1c and body weight at baseline and then at 26 weeks and 52 weeks of treatment.
Lowering HbA1c
Participants who took 3 mg oral semaglutide experienced a 0.5% greater decrease in HbA1c from baseline at 26 weeks of treatment compared with a 0.1% decrease for those using placebo at 26 weeks (P < .0001). In addition, participants who took 3 mg oral semaglutide experienced a 0.4% greater decrease in HbA1c compared with a 0.2% decrease for those taking placebo at 52 weeks (P = .0004).
Participants who took 7 mg oral semaglutide experienced a 0.9% greater decrease in HbA1c from baseline at 26 weeks of treatment compared with the 0.1% decrease for those using placebo at 26 weeks (P < .0001). In addition, participants who took 7 mg oral semaglutide experienced a 0.6% greater decrease in HbA1c compared with the 0.2% decrease for those taking placebo at 52 weeks (P < .0001).
Participants who took 14 mg oral semaglutide experienced a 1.2% greater decrease in HbA1c from baseline at 26 weeks of treatment compared with the 0.1% decrease for those using placebo at 26 weeks (P < .0001). In addition, participants who took 14 mg oral semaglutide experienced a 0.9% greater decrease in HbA1c compared with the 0.2% decrease for those taking placebo at 52 weeks (P < .0001).
Body weight effects
Body weight was lowered by 0.9 kg more with the 3 mg oral semaglutide regimen compared with a 0.4 kg decrease in body weight for those using placebo at 26 weeks (P = .0392) and by 1.3 kg more compared with a 0.5 kg increase for those taking placebo at 52 weeks (P = .0101).
Body weight was lowered by 2 kg more with the 7 mg oral semaglutide regimen compared with the 0.4 kg decrease in body weight for those using placebo at 26 weeks (P = .0001) and by 2.5 kg more compared with the 0.5 kg increase for those taking placebo at 52 weeks (P < .0001).
Body weight was lowered by 3.3 kg more with the 14 mg oral semaglutide regimen compared with a 0.4 kg decrease in body weight for those using placebo at 26 weeks (P < .0001) and by 4.3 kg more compared with the 0.5 kg increase for those taking placebo at 52 weeks (P < .0001).
For those taking oral semaglutide, nausea was the most frequently reported adverse event.
“These findings support the addition of GLP-1 receptor agonists as an effective treatment intensification strategy for patients who are unable to reach or maintain HbA1c targets with insulin alone, as recommended in current treatment guidelines,” the researchers wrote.
The PIONEER 8 trial further strengthens the evidence favoring oral semaglutide treatment in type 2 diabetes. As Endocrine Today previously reported, oral semaglutide treatment has bested treatment with empagliflozin (Jardiance, Boehringer Ingelheim) and sitagliptin (Januvia, Merck) and was noninferior compared with liraglutide (Victoza, Novo Nordisk). – by Phil Neuffer
Disclosures: Novo Nordisk funded the PIONEER 8 trial. Zinman reports he has served on the scientific advisory boards of and received honoraria or consultant fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
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