STRIDE: A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04560998
Collaborator
(none)
800
Enrollment
126
Locations
2
Arms
34.5
Anticipated Duration (Months)
6.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 13, 2022
Anticipated Study Completion Date :
Aug 17, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Semaglutide

Semaglutide given in addition to standard-of-care treatment

Drug: Semaglutide
Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.

Placebo Comparator: Placebo (semaglutide)

Placebo given in addition to standard-of-care treatment

Drug: Placebo (semaglutide)
Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.

Outcome Measures

Primary Outcome Measures

  1. Change in maximum walking distance on a constant load treadmill test [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

Secondary Outcome Measures

  1. Change in pain-free walking distance on a constant load treadmill test [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

  2. Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score [From baseline (week 0) to end of treatment (week 52)]

    Score on a scale. Vascular Quality of Life 6 (VascuQoL): A shorter version of the standardized, validated questionnaire, VascuQoL-25 which is used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 4 point response scale, with a score of 1 being the worst and a score of 4 the best possible. The total score is the sum of all 6 items scores. Each question relates to a separate domain, with a highest score of 4 which indicates best health outcome. The VascuQoL-6 is aimed specifically at PAD patients

  3. Follow-up change in maximum walking distance on a constant load treadmill test [From baseline (week 0) to end of follow-up (week 57)]

    Ratio to baseline

  4. Follow-up change in pain-free walking distance on a constant load treadmill test [From baseline (week 0) to end of follow-up (week 57)]

    Ratio to baseline

  5. Change in glycosylated haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 52)]

    Percentage point

  6. Change in body weight [From baseline (week 0) to end of treatment (week 52)]

    Kilogram

  7. Change in systolic blood pressure [From baseline (week 0) to end of treatment (week 52)]

    mmHg

  8. Change in total cholesterol [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

  9. Change in Low-density lipoprotein (LDL)- cholesterol [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

  10. Change in High density lipoprotein (HDL)- cholesterol [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

  11. Change in triglycerides [From baseline (week 0) to end of treatment (week 52)]

    Ratio to baseline

  12. Change in ankle-brachial index (ABI) [From screening (week -2) to end of treatment (week 52)]

    Ratio

  13. Change in toe-brachial index (TBI) [From screening (week -2) to end of treatment (week 52)]

    Ratio

  14. Change in Walking Impairment Questionnaire (WIQ) global score [From baseline (week 0) to end of treatment (week 52)]

    Percentage point

  15. Change in Short Form 36 (SF-36) physical functioning domain [From baseline (week 0) to end of treatment (week 52)]

    Score on a scale. Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health, of which will be summarised into a physical health. The physical score ranges from 24-101(where higher scores indicate a better physical capability). The domain scores will then be transformed into norm-based scores. At least seven domains must have valid data in order to calculate the physical health. To calculate physical health, the physical domain must be one of these seven domains. These scores will be summarised by domains and component summary scores by treatment and visit. A positive change in score indicates an improvement since baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at the time of signing informed consent

  • Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.

  • Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:

  1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.

  2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.

  3. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet.

  4. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).

Exclusion Criteria:
  • Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening.

  • Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinson's disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.).

  • Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).

  • Vascular revascularisation procedure of any kind 180 days prior to the day of screening.

  • Planned arterial revascularisation known on the day of screening.

  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.

  • Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteBirminghamAlabamaUnited States35211
2Novo Nordisk Investigational SiteLittle RockArkansasUnited States72205
3Novo Nordisk Investigational SiteLong BeachCaliforniaUnited States90813
4Novo Nordisk Investigational SiteLos AngelesCaliforniaUnited States90026
5Novo Nordisk Investigational SiteMission ViejoCaliforniaUnited States92691
6Novo Nordisk Investigational SiteAuroraColoradoUnited States80045
7Novo Nordisk Investigational SiteBrandonFloridaUnited States33511
8Novo Nordisk Investigational SiteClearwaterFloridaUnited States33756
9Novo Nordisk Investigational SiteClearwaterFloridaUnited States33761
10Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32216
11Novo Nordisk Investigational SitePinellas ParkFloridaUnited States33782
12Novo Nordisk Investigational SiteTampaFloridaUnited States33606
13Novo Nordisk Investigational SiteEatontonGeorgiaUnited States31024
14Novo Nordisk Investigational SiteMartinezGeorgiaUnited States30907
15Novo Nordisk Investigational SiteEvanstonIllinoisUnited States60201
16Novo Nordisk Investigational SiteSpringfieldIllinoisUnited States62701
17Novo Nordisk Investigational SiteMunsterIndianaUnited States46321
18Novo Nordisk Investigational SiteElizabethtownKentuckyUnited States42701
19Novo Nordisk Investigational SiteAlexandriaLouisianaUnited States71301
20Novo Nordisk Investigational SiteCovingtonLouisianaUnited States70433
21Novo Nordisk Investigational SiteMonroeLouisianaUnited States71201
22Novo Nordisk Investigational SiteBaltimoreMarylandUnited States21229
23Novo Nordisk Investigational SiteMinneapolisMinnesotaUnited States55407-1195
24Novo Nordisk Investigational SiteFestusMissouriUnited States63028
25Novo Nordisk Investigational SiteLebanonNew HampshireUnited States03756
26Novo Nordisk Investigational SiteNew YorkNew YorkUnited States10001
27Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
28Novo Nordisk Investigational SiteCamp HillPennsylvaniaUnited States17011
29Novo Nordisk Investigational SitePhiladelphiaPennsylvaniaUnited States19104
30Novo Nordisk Investigational SiteNashvilleTennesseeUnited States37232
31Novo Nordisk Investigational SiteAmarilloTexasUnited States79109
32Novo Nordisk Investigational SiteHoustonTexasUnited States77070
33Novo Nordisk Investigational SiteHumbleTexasUnited States77338
34Novo Nordisk Investigational SiteKingwoodTexasUnited States77339
35Novo Nordisk Investigational SiteLubbockTexasUnited States79430-8183
36Novo Nordisk Investigational SiteMcKinneyTexasUnited States75069
37Novo Nordisk Investigational SiteVictoriaTexasUnited States77901
38Novo Nordisk Investigational SiteWinchesterVirginiaUnited States22601-3834
39Novo Nordisk Investigational SiteGrazAustria8036
40Novo Nordisk Investigational SiteInnsbruckAustria6020
41Novo Nordisk Investigational SiteWienAustria1030
42Novo Nordisk Investigational SiteWienAustria1090
43Novo Nordisk Investigational SiteGenkBelgium3600
44Novo Nordisk Investigational SiteGentBelgium9000
45Novo Nordisk Investigational SiteKortrijkBelgium8500
46Novo Nordisk Investigational SiteLeuvenBelgium3000
47Novo Nordisk Investigational SiteNorth YorkOntarioCanadaM6B 3H7
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49Novo Nordisk Investigational SiteBrossardQuebecCanadaJ4Z 2K9
50Novo Nordisk Investigational SiteChicoutimiQuebecCanadaG7H 7K9
51Novo Nordisk Investigational SiteMontrealQuebecCanadaH1T 3Y7
52Novo Nordisk Investigational SiteMontrealQuebecCanadaQC H1T 1C8
53Novo Nordisk Investigational SitePQQuebecCanadaG1L 3L5
54Novo Nordisk Investigational SiteQuebecCanadaG1V 4G5
55Novo Nordisk Investigational SiteBeijingBeijingChina100053
56Novo Nordisk Investigational SiteChangchunJilinChina130021
57Novo Nordisk Investigational SiteXi'anShaanxiChina710061
58Novo Nordisk Investigational SiteTianjinChina300121
59Novo Nordisk Investigational SiteHodoninCzechia695 01
60Novo Nordisk Investigational SiteJaroměřCzechia55101
61Novo Nordisk Investigational SiteOstrava DubinaCzechia700 30
62Novo Nordisk Investigational SitePlzenCzechia30100
63Novo Nordisk Investigational SitePrahaCzechia128 08
64Novo Nordisk Investigational SiteKoldingDenmark6000
65Novo Nordisk Investigational SiteKøbenhavn ØDenmark2100
66Novo Nordisk Investigational SiteOdenseDenmark5000
67Novo Nordisk Investigational SiteViborgDenmark8800
68Novo Nordisk Investigational SiteBad HomburgGermany61348
69Novo Nordisk Investigational SiteBad OeynhausenGermany32545
70Novo Nordisk Investigational SiteDresdenGermany01277
71Novo Nordisk Investigational SiteDresdenGermany01307
72Novo Nordisk Investigational SiteFrankfurtGermany60389
73Novo Nordisk Investigational SiteLübeckGermany23562
74Novo Nordisk Investigational SiteMainzGermany55131
75Novo Nordisk Investigational SiteMünsterGermany48145
76Novo Nordisk Investigational SiteSaint Ingbert-OberwürzbachGermany66386
77Novo Nordisk Investigational SiteAthensGreeceGR-11527
78Novo Nordisk Investigational SiteAthensGreeceGR-14233
79Novo Nordisk Investigational SiteChiosGreeceGR82100
80Novo Nordisk Investigational SiteHaidari-AthensGreeceGR-12462
81Novo Nordisk Investigational SiteBudapestHungary1032
82Novo Nordisk Investigational SiteBudapestHungary1115
83Novo Nordisk Investigational SiteBudapestHungary1122
84Novo Nordisk Investigational SitePécsHungary7623
85Novo Nordisk Investigational SiteSzegedHungary6725
86Novo Nordisk Investigational SiteZalaegerszegHungary8900
87Novo Nordisk Investigational SiteChiba-shi, ChibaJapan260-0804
88Novo Nordisk Investigational SiteChibaJapan271-0077
89Novo Nordisk Investigational SiteHyogoJapan654-0026
90Novo Nordisk Investigational SiteHyogoJapan665-0873
91Novo Nordisk Investigational SiteIbaraki,Japan331-0133
92Novo Nordisk Investigational SiteIbarakiJapan311-0113
93Novo Nordisk Investigational SiteOsakaJapan559-0012
94Novo Nordisk Investigational SiteSaitamaJapan360-0197
95Novo Nordisk Investigational SiteShigaJapan525-8585
96Novo Nordisk Investigational SiteTokyoJapan192-0918
97Novo Nordisk Investigational SiteRigaLatviaLV-1002
98Novo Nordisk Investigational SiteKuala LumpurMalaysia59100
99Novo Nordisk Investigational SitePulau PinangMalaysia10990
100Novo Nordisk Investigational SiteSabahMalaysia88300
101Novo Nordisk Investigational SiteBergenNorway5021
102Novo Nordisk Investigational SiteKristiansandNorway4615
103Novo Nordisk Investigational SiteOsloNorway0586
104Novo Nordisk Investigational SiteKrakowPoland31-261
105Novo Nordisk Investigational SiteKrakowPoland31-271
106Novo Nordisk Investigational SitePoznanPoland60-111
107Novo Nordisk Investigational SitePulawyPoland24-100
108Novo Nordisk Investigational SiteWarszawaPoland04-628
109Novo Nordisk Investigational SiteWarszawaPoland05-077
110Novo Nordisk Investigational SiteWroclawPoland51-162
111Novo Nordisk Investigational SiteAlmeriaSpain04009
112Novo Nordisk Investigational SiteCórdobaSpain14004
113Novo Nordisk Investigational SiteMadridSpain28006
114Novo Nordisk Investigational SiteMadridSpain28007
115Novo Nordisk Investigational SiteMálagaSpain29009
116Novo Nordisk Investigational SiteSevillaSpain41009
117Novo Nordisk Investigational SiteGöteborgSweden413 45
118Novo Nordisk Investigational SiteUppsalaSweden751 85
119Novo Nordisk Investigational SiteKaoshiungTaiwan807
120Novo Nordisk Investigational SiteTaichungTaiwan404
121Novo Nordisk Investigational SiteTainan CityTaiwan704
122Novo Nordisk Investigational SiteTaipeiTaiwan100
123Novo Nordisk Investigational SiteTaipeiTaiwan112
124Novo Nordisk Investigational SiteTaoyuan cityTaiwan333
125Novo Nordisk Investigational SiteChiang MaiThailand50200
126Novo Nordisk Investigational SitePathumthaniThailand12120

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04560998
Other Study ID Numbers:
  • NN9535-4533
  • 2019-003399-38
  • U1111-1238-7071
First Posted:
Sep 23, 2020
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021