BARCELONA, Spain, Sept. 17, 2019 /PRNewswire/ -- Novo Nordisk today announced findings from an exploratory analysis of the PIONEER trial programme, showing oral semaglutide (3, 7 and 14 mg) improved glycaemic control in people with type 2 diabetes across baseline HbA1c levels. Greater reductions in HbA1c were demonstrated with 7 mg and 14 mg oral semaglutide vs all comparators including placebo, Jardiance® (empagliflozin 25 mg), Januvia® (sitagliptin 100 mg) or Victoza® (liraglutide 1.8 mg). The results were presented today at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD)1. Oral semaglutide is an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue in a pill.
In the analysis, data from 5,657 participants in PIONEER 1–5, 7 and 8 were grouped by trial according to baseline HbA1c (≤8.0%, >8.0–≤9.0% and >9.0%). The proportion of people with type 2 diabetes achieving an HbA1c target of <7% was greater with oral semaglutide 7 and 14 mg vs comparators in all trials and across all HbA1c baseline subgroups. Significant interactions by baseline HbA1c were observed for oral semaglutide vs the comparator in PIONEER 3 (14 mg), PIONEER 4 (14 mg vs placebo), and PIONEER 8 (7 and 14 mg).
"People with type 2 diabetes have individual treatment goals related to glycaemic control," said Dr Juris Meier, professor of medicine and head of the division of diabetology and GI endocrinology at the St. Josef-Hospital of the Ruhr-University of Bochum, Germany. "The findings from this analysis are particularly meaningful as they show that oral semaglutide improves glycaemic control across a spectrum of baseline glucose levels."
The safety profile of oral semaglutide across the PIONEER programme was consistent with that of the GLP-1 receptor agonist class and similar to those seen with subcutaneous semaglutide.
"This analysis reinforces the findings seen throughout the PIONEER trial programme, demonstrating oral semaglutide's efficacy in HbA1c reductions compared to commonly used type 2 diabetes treatments," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "If approved, oral semaglutide will become the first and only oral GLP-1 receptor agonist with the potential to help people with uncontrolled type 2 diabetes better manage their condition."
About the exploratory analysis and the PIONEER clinical trial programme
The PIONEER 1-5, 7 and 8 trials, included in this analysis, investigated oral semaglutide against diet and exercise (PIONEER 1), empagliflozin 25 mg (PIONEER 2), sitagliptin 100 mg (PIONEER 3 and 7), liraglutide 1.8 mg (PIONEER 4) and as an add on to insulin (PIONEER 8). PIONEER 5 evaluated oral semaglutide compared to placebo in patients with renal impairment.
The PIONEER phase 3a clinical development programme for oral semaglutide was a global development programme that enrolled 9,543 people with type 2 diabetes across 10 clinical trials.
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries and markets its products in more than 170 countries.
1. Meier JJ, Bauer R, Blicher TM, et al. Efficacy of oral semaglutide according to baseline HbA1c: an exploratory subgroup analysis of the PIONEER trial programme. 55th Annual Meeting of the European Association for the Study of Diabetes. Barcelona, September 2019.
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