Most adults with prediabetes achieve normoglycemia at 68 weeks with oral semaglutide
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Key takeaways:
- Adults with prediabetes receiving oral semaglutide 50 mg reduced their HbA1c by 0.38 percentage points at 68 weeks.
- Most participants with prediabetes in the semaglutide group achieved normoglycemia at 68 weeks.
DALLAS — Oral semaglutide improves HbA1c and may prevent progression to type 2 diabetes for adults with prediabetes, according to a speaker at ObesityWeek.
As Healio previously reported, high-dose oral semaglutide 50 mg (Novo Nordisk) induced a 15.1% weight loss at 68 weeks for adults with obesity. In a subanalysis of OASIS 1 focused on adults with an HbA1c between 5.7% and 6.4% at baseline, those with prediabetes receiving oral semaglutide lost 14.4% of their body weight at 68 weeks, and HbA1c decreased by 0.38 percentage points from baseline to 68 weeks.
“Those people who participated in the OASIS 1 trial with prediabetes who received oral semaglutide experienced more HbA1c normalization and none progressed to type 2 diabetes,” Julio Rosenstock, MD, FACE, director of Velocity Clinical Research at Medical City Dallas and clinical professor of medicine at the University of Texas Southwestern Medical Center, said during a presentation.
OASIS 1 is a phase 3, randomized, double-blind trial in which 667 adults with overweight or obesity and without type 2 diabetes were randomly assigned to once-daily oral semaglutide 50 mg or placebo plus lifestyle intervention for 68 weeks. The subanalysis presented at ObesityWeek analyzed data from 262 adults with prediabetes, defined as an HbA1c between 5.7% and 6.4%. Researchers examined change in HbA1c, fasting plasma glucose, fasting serum insulin and body weight from baseline to 68 weeks. Categorical weight loss and safety data were also collected.
The subanalysis included 132 adults who received oral semaglutide (74% women; mean age, 54 years) and 130 adults who received placebo (66% women; mean age, 53 years). In the treatment-policy estimand, adults with prediabetes receiving oral semaglutide lost 14.4% of their body weight at 68 weeks compared with a 2.5% weight loss for the placebo group (P < .0001). FPG declined by 12.3 mg/dL at 68 weeks for those receiving oral semaglutide vs. a 1.6 mg/dL reduction with placebo (P < .0001). The oral semaglutide group had a 0.38 percentage point decline in HbA1c at 68 weeks vs. a 0.02 percentage point HbA1c increase for the placebo group (P < .0001). Fasting serum insulin levels decreased by 33% at 68 weeks for the oral semaglutide group vs. a 9% decline for adults receiving placebo (P < .0001).
“Greater magnitudes of body weight loss were associated with greater improvements in glycemic control with oral semaglutide 50 mg,” Rosenstock said.
Of adults with prediabetes at baseline, 87.9% of the placebo group still had prediabetes at 68 weeks and 1.7% developed type 2 diabetes with an HbA1c of 6.5% or higher. In the oral semaglutide group, there were no adults who developed type 2 diabetes, and 75.8% of those with prediabetes at baseline had normoglycemia at 68 weeks with an HbA1c of less than 5.7%.
Adverse events for adults included in the subanalysis were reported by 84.2% of the placebo group and 91% of the oral semaglutide group. Gastrointestinal-related adverse events were more common in the oral semaglutide group vs. the placebo group (81.3% vs. 45.1%). Severe adverse events were similar between the two groups and there were no deaths reported among adults with prediabetes.
“The safety profile of oral semaglutide 50 mg in those people with prediabetes was consistent with the overall cohort population safety profile,” Rosenstock said.
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Rosenstock J, et al. Oral-088. Presented at: ObesityWeek; Oct. 14-17, 2023; Dallas.
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