The PIONEER phase 3a clinical development programme for oral semaglutide is a global development programme with an expected enrolment of more than 9,000 people with type 2 … Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84). Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide.
The dropout rate for the treatment arms ranged from 2% to 7% for oral semaglutide versus 2% for placebo. In PIONEER 2, oral semaglutide (Novo Nordisk) was associated with superior HbA1c reductions vs. the oral SGLT2 inhibitor empagliflozin (Jardiance, …
At 26 weeks, people in the oral semaglutide group experienced a statistically significant greater reduction in HbA1c than those receiving empagliflozin (1.9% vs 0.9%). Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg. PIONEER 2 was a 52-week, randomised, open-label, active-controlled, parallel-group, multicentre, multinational trial with two arms comparing the efficacy and safety of oral semaglutide … One of a series of 10 phase 3 trials of oral semaglutide, PIONEER-3 evaluated the drug's efficacy and safety against sitagliptin, a commonly prescribed oral glucose-lowering agent for type 2 diabetes. 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 …
1 The program has a global enrollment of 8,845 people with type 2 diabetes across 10 clinical trials, which are all expected to completed in 2018.
More PIONEER Studies Around The Corner. The PIONEER 10 trial is part the PIONEER phase 3a clinical development program for oral semaglutide.
The mean pulse rate increased by 2 and 2.5 bpm with 0.5 and 1.0 mg dose of semaglutide in SUSTAIN 6, and by 4 bpm in PIONEER 6. Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes (PIONEER 3) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Overall, the pivotal PIONEER program includes 8,845 patients and multiple readouts this year. PIONEER 2 (NCT02863328) was an open-label study that compared oral semaglutide (14 mg) with empagliflozin in 816 patients with T2D inadequately controlled by metformin. In PIONEER 1, the rate of nausea in the highest dose tested – 14 mg – was 16%.
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