Secondary data at 52 weeks demonstrated statistically significant blood sugar reductions and statistically significant reduction of body weight vs both Jardiance® and Victoza®

SAN FRANCISCO, June 8, 2019 /PRNewswire/ -- Findings presented today from two phase 3a clinical trials evaluated oral semaglutide 14 mg vs Jardiance^® (empagliflozin 25 mg) in PIONEER 2 and oral semaglutide 14 mg vs Victoza^® (liraglutide 1.8 mg) in PIONEER 4 over 52 weeks in adults with type 2 diabetes. Data from both trials were presented at the American Diabetes Association (ADA) 79^th Scientific Sessions. Oral semaglutide is an investigational once-daily glucagon-like peptide-1 (GLP-1) analog in a pill.

In PIONEER 2, oral semaglutide 14 mg demonstrated a superior A1C 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 A1C 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 (3.8 kg for oral semaglutide at both 26 and 52 weeks, 3.7 kg and 3.6 kg for empagliflozin, respectively).

In PIONEER 4, for the primary endpoint at 26 weeks, oral semaglutide 14 mg demonstrated a non-inferior reduction in A1C vs Victoza^® (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 A1C vs both Victoza^® (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 Victoza^® and placebo at 26 weeks (4.4 kg for oral semaglutide, 3.1 kg for Victoza^® and 0.5 kg for placebo) and statistically significant reductions compared to both at 52 weeks (4.3 kg for oral semaglutide, 3.0 kg for Victoza^® and 1.0 kg 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 Victoza^® 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 Victoza^® 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 safety and efficacy, GLP-1 receptor agonists are underutilized in clinical care," said Dr. 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 new treatment option for people living with type 2 diabetes."

The following results from PIONEER 2 and 4 were also presented today at ADA and are based on the secondary statistical approach. The secondary statistical approach 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:

PIONEER 2:

• Oral semaglutide demonstrated statistically significant reductions in A1C vs empagliflozin at 26 weeks (1.4% vs 0.9%, respectively) and at 52 weeks (1.3% vs 0.8%, respectively).
• Oral semaglutide demonstrated a body weight reduction of 4.2 kg vs 3.8 kg with empagliflozin at 26 weeks and a statistically significant reduction of 4.7 kg vs 3.8 kg at 52 weeks.

PIONEER 4:

• Oral semaglutide demonstrated statistically significant reductions in A1C vs Victoza^® and vs placebo at both 26 and 52 weeks (1.3% for oral semaglutide, 1.1% for Victoza^® and 0.1% for placebo at 26 weeks; 1.2% for oral semaglutide, 0.9% for Victoza^® and a 0.2% increase for placebo at 52 weeks).
• Oral semaglutide demonstrated statistically significant reductions in body weight vs Victoza^® and vs placebo at both 26 and 52 weeks (4.7 kg for oral semaglutide, 3.2 kg for Victoza^® and 0.7 kg for placebo at 26 weeks; 5.0 kg for oral semaglutide, 3.1 kg for Victoza^® and 1.2 kg for placebo at 52 weeks).

About PIONEER 2, PIONEER 4 and the PIONEER clinical trial program
PIONEER 2 was a 52-week, randomized, open-label, active-controlled, parallel-group, multicenter, multinational trial with two arms comparing the efficacy and safety of oral semaglutide 14 mg with empagliflozin 25 mg in people with type 2 diabetes, inadequately controlled on metformin. 822 people were enrolled in PIONEER 2 and randomized 1:1 to receive either oral semaglutide or empagliflozin once daily. The primary endpoint was change in A1C from baseline to week 26 and the confirmatory secondary endpoint was change in body weight from baseline to week 26. Additional key secondary endpoints included change in A1C and body weight from baseline to week 52.

PIONEER 4 was a 52-week, randomized, double-blinded, double-dummy, active- and placebo-controlled, parallel-group, multicenter, multinational trial with three arms comparing the efficacy and safety of oral semaglutide 14 mg compared to Victoza^® (1.8 mg liraglutide) or placebo in people with type 2 diabetes, inadequately controlled on metformin with or without an SGLT-2 inhibitor. PIONEER 4 randomized 711 people in a 2:2:1 manner to receive either oral semaglutide, Victoza^® or placebo once daily. The primary endpoint was change from baseline to week 26 in A1C. Key secondary endpoints included change in A1C and body weight from baseline to week 52.

The PIONEER phase 3a clinical development program for oral semaglutide is a global development program that enrolled 9,543 people with type 2 diabetes across 10 clinical trials.

About Novo Nordisk 
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

References

1. Montanya E, Rosenstock J, Canani LH, et al. Oral semaglutide vs empagliflozin added-on to metformin monotherapy in uncontrolled type 2 diabetes: PIONEER 2. Abstract number 54-OR, American Diabetes Association 79^th Scientific Sessions, San Francisco, C.A.; June 7-11, 2019.
2. Pratley RE, Amod A, Hoff ST, et al. Oral Semaglutide vs Liraglutide and Placebo in T2D: PIONEER 4. Abstract number 55-OR, American Diabetes Association 79^th Scientific Sessions, San Francisco, C.A.; June 7-11, 2019.

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