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Phase IIIa clinical trial data presented for oral semaglutide


10 June, 2019  
Findings presented from two Phase IIIa clinical trials evaluated oral semaglutide 14mg vs Jardiance® (empagliflozin 25mg) in PIONEER 2 and oral semaglutide 14mg versus Victoza® (liraglutide 1.8mg) in PIONEER 4 over 52 weeks in adults with type 2 diabetes. 
 
Data from both trials were presented at the American Diabetes Association (ADA) 79th Scientific Sessions. 
 
In PIONEER 2, oral semaglutide 14 mg demonstrated a superior HbA1c reduction of 1.3% compared to a 0.9% reduction with empagliflozin 25 mg for the primary endpoint at 26 weeks (p<0.0001) and a statistically significant reduction in HbA1c for the secondary endpoint at 52 weeks. Furthermore, for the secondary endpoint, the reduction in body weight with oral semaglutide was similar to empagliflozin with no statistical differences at both 26 and 52 weeks (3.8kg for oral semaglutide at both 26 and 52 weeks, 3.7kg and 3.6kg for empagliflozin, respectively).
 
In PIONEER 4, for the primary endpoint at 26 weeks, oral semaglutide 14 mg demonstrated a non-inferior reduction in HbA1c vs liraglutide 1.8mg (1.2% vs 1.1%, respectively) and a superior reduction vs placebo (1.2% vs 0.2%, respectively) in adults with type 2 diabetes inadequately controlled on metformin, with or without a sodium-glucose co-transporter-2 (SGLT-2) inhibitor. For the secondary endpoint at 52 weeks, oral semaglutide demonstrated statistically significant reductions in HbA1c vs both liraglutide 1.8mg (1.2% vs 0.9%, respectively) and placebo (1.2% vs 0.2%, respectively). For the secondary endpoint of change in body weight, oral semaglutide demonstrated superior reductions compared to both liraglutide 1.8mg and placebo at 26 weeks (4.4 kg for oral semaglutide, 3.1kg for liraglutide 1.8mg and 0.5kg for placebo) and statistically significant reductions compared to both at 52 weeks (4.3 kg for oral semaglutide, 3.0kg for liraglutide 1.8mg and 1.0kg for placebo).
 
In PIONEER 2, the most common adverse event for oral semaglutide was nausea, which diminished over time, affecting 20% of people treated with oral semaglutide. The nausea rate for empagliflozin was 2%. The proportion of people who discontinued treatment due to adverse events was 11% for those treated with oral semaglutide compared to 4% for those treated with empagliflozin.
 
In PIONEER 4, the most common adverse event for oral semaglutide was nausea, which diminished over time, affecting 20% of people treated with oral semaglutide. For people treated with liraglutide 1.8mg and placebo, 18% and 4%, respectively, experienced nausea. The proportion of people who discontinued treatment due to adverse events was 11% for those treated with oral semaglutide compared to 9% with liraglutide 1.8mg and 4% with placebo.
 
These results are based on the primary statistical approach known as the treatment policy (TPol) estimand, which was used to assess the effects of oral semaglutide regardless of discontinuation of trial product and/or use of rescue medication.
 
Despite their proven efficacy and safety profile, GLP-1 receptor agonists are underutilised in clinical care” said Ildiko Lingvay, PIONEER 2 and 4 investigator and professor at the Departments of Internal Medicine and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas. “As a treating physician, I’m encouraged by these findings and the potential of investigational oral semaglutide to be the first oral GLP-1 receptor agonist available as a treatment option for people living with type 2 diabetes.”