On Friday, Novo Nordisk announced the results from PIONEER 1, a phase 3a trial featuring oral semaglutide for treatment of adults with type 2 diabetes (T2D). Oral semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue taken once daily as a tablet, making this investigational therapy the first oral treatment in this class.
On Friday, Novo Nordisk announced the results from PIONEER 1, a phase 3a trial featuring oral semaglutide for treatment of adults with type 2 diabetes (T2D). Oral semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue taken once daily as a tablet, making this investigational therapy the first oral treatment in this class.
In December 2017, the FDA approved the pre-filled pen version of Novo Nordisk’s semaglutide.
The global 26-week trial investigated the efficacy and safety of 3 mg, 7 mg, and 14 mg doses of oral semaglutide compared with placebo in 703 people with T2D.
Two approaches were used in evaluating the efficacy of oral semaglutide in the PIONEER 1 trial: a primary statistical principle required by recent regulatory guidelines evaluating the effect regardless of treatment adherence, and a secondary method of describing the effect if participants had adhered to treatment and did not initiate rescue medication.
The first objective was achieved by demonstrating a significant and superior improvement in glycated hemoglobin (A1C) for all 3 doses of oral semaglutide compared with placebo. In addition, the 14 mg dose also demonstrated significant weight loss compared with placebo; weight loss for 7 mg and 3 mg doses did not reach statistical significance.
When evaluating the secondary objective of the study, patients treated with 3 mg, 7 mg, and 14 mg doses of oral semaglutide achieved reductions in A1C of 0.8%, 1.3%, and 1.5%, respectively, compared with a reduction of 0.1% in people treated with placebo from a mean baseline of 8%. The American Diabetes Association (ADA) treatment target of A1C below 7% was achieved by 59%, 72%, and 80% of people treated with 3 mg, 7 mg, and 14 mg doses, respectively, compared with 34% of people treated with placebo.
Results showed oral semaglutide appeared to have a safe and well-tolerated clinical profile. The most common adverse effect for all 3 doses was mild to moderate nausea, which diminished over time. Between 5% and 16% of people treated experienced nausea.
“We are very encouraged by the results of the PIONEER 1 trial, which confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes. We look forward to providing data from the remaining 9 PIONEER trials throughout this year and an expected regulatory submission in 2019,” Mads Krogsgaard Thomsen, DVM, PhD, executive vice president and chief science officer of Novo Nordisk said in a statement.
Beyond Insulin: The Impact of Next-Generation Diabetes Technology
April 17th 2024Experts explain how new diabetes technologies like continuous glucose monitors are transforming care beyond intensive insulin therapy, offering personalized insights and improving outcomes for patients of all treatment levels.
Read More
How Can Employers Leverage the DPP to Improve Diabetes Rates?
February 15th 2022On this episode of Managed Care Cast, Jill Hutt, vice president of member services at the Greater Philadelphia Business Coalition on Health, explains the Coalition’s efforts to reduce diabetes rates through the Diabetes Prevention Program (DPP).
Listen
Balancing Care Access and Fragmentation for Better Outcomes in Veterans With Diabetes
April 22nd 2021The authors of a study in the April 2021 issue of The American Journal of Managed Care® discuss the possible reasons behind the link between care fragmentation and hospitalizations in veterans with diabetes, as well as potential opportunities to address disjointed care in the context of the widespread telehealth uptake seen during the COVID-19 pandemic.
Listen