Trial results for a Phase 3 study evaluating semaglutide for peripheral arterial disease (PAD) and type 2 diabetes were posted on ClinicalTrials.gov on 2024-06-05. The study demonstrated that semaglutide led to a median change in maximum walking distance of 1.21 compared to 1.08 for placebo, and a median change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score of 2.0 versus 1.0 for placebo.
Background
The study investigated semaglutide in people with peripheral arterial disease (PAD) and type 2 diabetes. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. The trial aimed to assess the effect of semaglutide on walking ability compared with placebo in this patient population.
Trial design
The Phase 3 study (NCT04560998) enrolled 792 participants with type 2 diabetes and peripheral arterial disease. The trial compared semaglutide against placebo to evaluate its effect on walking ability. Participants received the study medicine, either semaglutide or placebo, administered once weekly via injection into the stomach area, thigh, or upper arm.
Key results
The trial reported several key outcome measurements:
- For Change in Maximum Walking Distance on a Constant Load Treadmill Test, the median ratio was 1.21 for the semaglutide group and 1.08 for the placebo group.
- For Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test, the median ratio was 1.16 for semaglutide and 1.10 for placebo.
- The median Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score was 2.0 for semaglutide and 1.0 for placebo.
- For Change in Pain-free Walking Distance on a Constant Load Treadmill Test, the median ratio was 1.21 for semaglutide and 1.10 for placebo.
- For Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test, the median ratio was 1.18 for semaglutide and 1.10 for placebo.
- The mean Change in Glycosylated Haemoglobin (HbA1c) was -0.8 percentage-point (Standard Deviation: 1.1) for semaglutide and 0.2 percentage-point (Standard Deviation: 1.1) for placebo.
Key analyses using the Wilcoxon (Mann-Whitney) method showed statistically significant differences:
- For one outcome, the Hodges-Lehmann estimate was 1.13 (95.0% CI: 1.056, 1.211) with a p-value of 0.0004.
- Another analysis yielded a Hodges-Lehmann estimate of 1.08 (95.0% CI: 1.004, 1.156) with a p-value of 0.038.
- A further analysis showed a Hodges-Lehmann estimate of 1.0 (95.0% CI: 0.478, 1.518) with a p-value of 0.0108.
- Another analysis resulted in a Hodges-Lehmann estimate of 1.11 (95.0% CI: 1.033, 1.197) with a p-value of 0.0046.
What this means
The results from this Phase 3 trial suggest that semaglutide may offer clinical benefits for individuals with peripheral arterial disease and type 2 diabetes. The observed improvements in maximum walking distance, pain-free walking distance, and vascular quality of life scores indicate a positive impact on functional capacity and patient-reported outcomes. Additionally, the reduction in HbA1c further supports semaglutide's known efficacy in glycemic control. The statistically significant p-values from the analyses reinforce the reliability of these findings, suggesting that semaglutide could be a valuable treatment option for improving mobility and overall quality of life in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04560998, titled "A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes", were posted on 2024-06-05 on clinicaltrials.gov.