PIONEER data support oral semaglutide across a wide range of patients
medwireNews: Researchers at the 55th EASD Annual Meeting in Barcelona, Spain, have presented primary data and subanalyses from a number of the PIONEER trials investigating the efficacy of oral semaglutide in people with type 2 diabetes.
In PIONEER 2, the investigators showed that glycated hemoglobin (HbA1c) levels fell by a mean of 1.3% (14 mmol/mol) after 26 weeks of using oral semaglutide 14 mg daily among patients with type 2 diabetes uncontrolled on metformin. This was significantly greater than the mean 0.9% (9 mmol/mol) reduction that occurred among patients using the comparator drug empagliflozin 25 mg daily, with the difference between the groups remaining significant at 52 weeks.
There was no difference in weight change between participants receiving semaglutide and those receiving empagliflozin at 26 weeks, but by 52 weeks individuals in the semaglutide group had lost significantly more weight than those in the empagliflozin group (mean 4.7 vs 3.8 kg).
In PIONEER 8, the researchers investigated the effect of adding semaglutide to insulin. They observed significantly greater dose-dependent reductions in both mean HbA1c and body weight with semaglutide versus placebo at both 26 and 52 weeks.
For example, at week 26, patients receiving semaglutide 3 mg, 7 mg, and 14 mg in combination with insulin (with or without metformin) had mean 0.6%, 0.9%, and 1.3% reductions in HbA1c, respectively, whereas those receiving placebo experienced a reduction of just 0.1%. Corresponding average weight loss in the four groups at week 26 was 1.4 kg, 2.4 kg, 3.7 kg and 0.4 kg, respectively.
A subgroup analysis of patients from PIONEER 1–5, 7, and 8 explored the efficacy of oral semaglutide according to diabetes duration. And although the mean diabetes duration at baseline ranged from 3.5 to 15.0 years across the trials, the researchers found that the estimated treatment differences for HbA1c at week 26 were consistent across diabetes duration subgroups.
In addition, they showed that the estimated odds of achieving an HbA1c below the target level of 7.0% were greater with oral semaglutide 7 mg and 14 mg than with the comparators in each of the trials, irrespective of diabetes duration.
The second subanalysis grouped PIONEER 1–5, 7, and 8 participants according to baseline HbA1c and showed that although reductions in HbA1c were greater with oral semaglutide 7 mg and 14 mg versus comparator in all subgroups, the reduction increased with increasing baseline HbA1c.
For example, in PIONEER 2 participants who received semaglutide 14 mg, the mean reductions in HbA1c at week 26 were 1.0%, 1.8%, and 2.0%, for those with baseline HbA1c levels below 8.0%, between 8.0% and 9.0%, and above 9.0%, respectively.
In all of the studies, the researchers found that semaglutide was well tolerated and had a safety profile that was consistent with that of other glucagon-like peptide-1 receptor agonists as well as that of subcutaneous semaglutide.
They conclude that the findings support the use of oral semaglutide across a broad population of patients with type 2 diabetes.
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group