Analysis Shows Oral Semaglutide Beats Empagliflozin for Reducing Blood Sugar
An analysis of phase 3 trial data for the investigational type 2 diabetes (T2D) drug oralSemaglutide Reviews shows the glucagon-like peptide 1 (GLP-1) receptor agonist does a better job reducing blood sugar than empagliflozin, a leading sodium glucose co-transporter 2 (SGLT2) inhibitor and the first T2D drug shown to offer cardiovascular benefits.
Other phase 3 results presented Saturday at the 79th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California, show that oral semaglutide would produce more weight loss than liraglutide, the daily injectable GLP-1 receptor agonist sold as Victoza. Novo Nordisk makes both products.
In March, Novo Nordisk filed a new drug application for oral semaglutide, and also sought cardiovascular indications for both the oral and injectable form of the drug. FDA approved the once-weekly injectable formulation of semaglutide, sold as Ozempic, in December 2017. Cardiovascular results for oral semaglutide will be presented Tuesday at ADA and are among the most anticipated results of the meeting.
In a statement, Novo Nordisk said results from PIONEER 2, comparing oral semaglutide and empagliflozin, and PIONEER 4, comparing oral semaglutide to liraglutide, are based on the secondary statistical approach. The approach, the statement said, “is known as the trial product estimand and is used to assess the effect of oral semaglutide, assuming all patients remained on trial product and did not use rescue medication.”
Results for PIONEER 2 show:
Oral semaglutide produced statistically significant reductions in glycated hemoglobin (A1C) compared with empagliflozin, which is sold by Eli Lilly and Boehringer Ingelheim as Jardiance. Results at 26 weeks showed that oral semaglutide produced an A1C reduction of 1.4% compared with 0.9% for empagliflozin; the results were sustained at 52 weeks, with A1C reductions of 1.3% vs 0.8%, respectively.
More patients taking oral semaglutide achieved an A1C <7.0% than with empagliflozin. PIONEER 2 also showed that oral semaglutide demonstrated weight loss of 4.2 kg compared with 3.8 kg for empagliflozin at 26 weeks. A statistically significant difference in weight loss was seen at 52 weeks: 4.7 kg for oral semaglutide vs 3.8 kg for empagliflozin. Results for PIONEER 4 show: Oral semaglutide produced statistically significant reductions in A1C compared with both liraglutide and placebo, at both 26 and 52 weeks. A1C reductions at 26 weeks were 1.3% for oral semaglutide, 1.1% for liraglutide and 0.1% for; at 52 weeks, A1C reductions were 1.2% for oral semaglutide and 0.9% for liraglutide, while placebo showed a 0.2% increase in A1C. Oral semaglutide demonstrated statistically significant weight loss compared with both liraglutide and placebo, at both 26 and 52 weeks. Weight loss at 26 weeks was 4.7 kg for oral semaglutide, 3.2 kg for liraglutide and 0.7 kg for placebo; at 52 weeks, reductions were 5.0 kg for oral semaglutide, 3.1 kg for liraglutide and 1.2 kg for placebo at 52 weeks.