Trial · NCT04560998
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
NCT04560998, Phase 3, Completed, Novo Nordisk A/S; results first posted 2025-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes. Trials, record NCT04560998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04560998
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
- NCT number
- NCT04560998
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 792 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 2, Peripheral Arterial Disease
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2020-09-23
- Last updated
- 2026-06-05
- Other registries' IDs
- eudract:2019-003399-38
- Results first posted
- 2025-07-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Maximum Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of treatment (week 52) | Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of follow-up (week 57) | Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score | Baseline (week 0), end of treatment (week 52) | Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of treatment (week 52) | Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of follow-up (week 57) | Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | Baseline (week 0), end of treatment (week 52) | Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). |
| Secondary | Change in Body Weight | Baseline (week 0), end of treatment (week 52) | Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). |
| Secondary | Change in Systolic Blood Pressure | Baseline (week 0), end of treatment (week 52) | Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). |
| Secondary | Change in Total Cholesterol | Baseline (week 0), end of treatment (week 52) | Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). |
| Secondary | Change in Low-density Lipoprotein (LDL)-Cholesterol | Baseline (week 0), end of treatment (week 52) | Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Maximum Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of maximum walking distance | MEDIAN |
| SECONDARY | Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of follow-up (week 57) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of maximum walking distance | MEDIAN |
| SECONDARY | Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Scores on a scale | MEDIAN |
| SECONDARY | Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of pain-free walking distance | MEDIAN |
| SECONDARY | Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Baseline (week 0), end of follow-up (week 57) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of pain-free walking distance | MEDIAN |
| SECONDARY | Change in Glycosylated Haemoglobin (HbA1c) | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Percentage-point of HbA1c | MEAN |
| SECONDARY | Change in Body Weight | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Kilogram (kg) | MEAN |
| SECONDARY | Change in Systolic Blood Pressure | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Millimetre of mercury (mmHg) | MEAN |
| SECONDARY | Change in Total Cholesterol | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of total cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change in Low-density Lipoprotein (LDL)-Cholesterol | Baseline (week 0), end of treatment (week 52) | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Ratio of LDL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Maximum Walking Distance on a Constant Load Treadmill Test | Semaglutide | 1.21 | Inter-Quartile Range 0.95 to 1.55 | Ratio of maximum walking distance | |
| Change in Maximum Walking Distance on a Constant Load Treadmill Test | Placebo | 1.08 | Inter-Quartile Range 0.86 to 1.36 | Ratio of maximum walking distance | |
| Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test | Semaglutide | 1.16 | Inter-Quartile Range 0.92 to 1.48 | Ratio of maximum walking distance | |
| Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test | Placebo | 1.10 | Inter-Quartile Range 0.87 to 1.40 | Ratio of maximum walking distance | |
| Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score | Semaglutide | 2.0 | Inter-Quartile Range 0.00 to 4.00 | Scores on a scale | |
| Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score | Placebo | 1.0 | Inter-Quartile Range -1.00 to 4.00 | Scores on a scale | |
| Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Semaglutide | 1.21 | Inter-Quartile Range 0.92 to 1.52 | Ratio of pain-free walking distance | |
| Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Placebo | 1.10 | Inter-Quartile Range 0.86 to 1.44 | Ratio of pain-free walking distance | |
| Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Semaglutide | 1.18 | Inter-Quartile Range 0.92 to 1.59 | Ratio of pain-free walking distance | |
| Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Placebo | 1.10 | Inter-Quartile Range 0.83 to 1.48 | Ratio of pain-free walking distance |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 396 | |
| Overall Study | STARTED | Placebo | 396 | |
| Overall Study | Full Analysis Set | Semaglutide | 396 | |
| Overall Study | Full Analysis Set | Placebo | 396 | |
| Overall Study | Safety Analysis Set | Semaglutide | 396 | |
| Overall Study | Safety Analysis Set | Placebo | 395 | |
| Overall Study | COMPLETED | Semaglutide | 366 | |
| Overall Study | COMPLETED | Placebo | 379 | |
| Overall Study | NOT COMPLETED | Semaglutide | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Semaglutide | 30 | 396 | 32 |
| other | COVID-19 | Infections and infestations | Placebo | 21 | 395 | 21 |
| other | Nausea | Gastrointestinal disorders | Semaglutide | 22 | 396 | 26 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 395 | 4 |
| serious | Abdominal abscess | Infections and infestations | Semaglutide | 0 | 396 | 0 |
| serious | Abdominal abscess | Infections and infestations | Placebo | 1 | 395 | 1 |
| serious | Abdominal symptom | Gastrointestinal disorders | Semaglutide | 1 | 396 | 1 |
| serious | Abdominal symptom | Gastrointestinal disorders | Placebo | 0 | 395 | 0 |
| serious | Abscess limb | Infections and infestations | Semaglutide | 0 | 396 | 0 |
| serious | Abscess limb | Infections and infestations | Placebo | 1 | 395 | 1 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 4 | 396 |
| Total, all-cause mortality | Placebo | 9 | 395 |
| Total, other adverse events | Semaglutide | 47 | 396 |
| Total, other adverse events | Placebo | 24 | 395 |
| Total, serious adverse events | Semaglutide | 74 | 396 |
| Total, serious adverse events | Placebo | 78 | 395 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40169145 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide vs Placebo: deaths from any cause | Trial comparisons |
| Semaglutide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04560998
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