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)
• Enrollment: 800
• Locations: 150
• Arms: 2
• Anticipated Duration (Months): 34.5
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.2

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 Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Peripheral Arterial Disease	Drug: Semaglutide; Drug: Placebo (semaglutide)	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35211
2	Novo Nordisk Investigational Site	Little Rock	Arkansas	United States	72205
3	Novo Nordisk Investigational Site	Long Beach	California	United States	90813
4	Novo Nordisk Investigational Site	Los Angeles	California	United States	90010
5	Novo Nordisk Investigational Site	Mission Viejo	California	United States	92691
6	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
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8	Novo Nordisk Investigational Site	Clearwater	Florida	United States	33756
9	Novo Nordisk Investigational Site	Clearwater	Florida	United States	33761
10	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
11	Novo Nordisk Investigational Site	Pinellas Park	Florida	United States	33782
12	Novo Nordisk Investigational Site	Tampa	Florida	United States	33606
13	Novo Nordisk Investigational Site	Eatonton	Georgia	United States	31024
14	Novo Nordisk Investigational Site	LaGrange	Georgia	United States	30240
15	Novo Nordisk Investigational Site	Martinez	Georgia	United States	30907
16	Novo Nordisk Investigational Site	Evanston	Illinois	United States	60201
17	Novo Nordisk Investigational Site	Springfield	Illinois	United States	62701
18	Novo Nordisk Investigational Site	Munster	Indiana	United States	46321
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28	Novo Nordisk Investigational Site	Lebanon	New Hampshire	United States	03756
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43	Novo Nordisk Investigational Site	Innsbruck		Austria	6020
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45	Novo Nordisk Investigational Site	Wien		Austria	1090
46	Novo Nordisk Investigational Site	Bonheiden		Belgium	2820
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50	Novo Nordisk Investigational Site	Leuven		Belgium	3000
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90	Novo Nordisk Investigational Site	Budapest		Hungary	1122
91	Novo Nordisk Investigational Site	Pécs		Hungary	7623
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106	Novo Nordisk Investigational Site	Kuala Lumpur		Malaysia	59100
107	Novo Nordisk Investigational Site	Pulau Pinang		Malaysia	10990
108	Novo Nordisk Investigational Site	Sabah		Malaysia	88300
109	Novo Nordisk Investigational Site	Sungai Buloh		Malaysia	47000
110	Novo Nordisk Investigational Site	Bergen		Norway	5021
111	Novo Nordisk Investigational Site	Kristiansand		Norway	4615
112	Novo Nordisk Investigational Site	Oslo		Norway	0586
113	Novo Nordisk Investigational Site	Krakow		Poland	31-261
114	Novo Nordisk Investigational Site	Krakow		Poland	31-271
115	Novo Nordisk Investigational Site	Poznan		Poland	60-111
116	Novo Nordisk Investigational Site	Pulawy		Poland	24-100
117	Novo Nordisk Investigational Site	Warszawa		Poland	04-628
118	Novo Nordisk Investigational Site	Warszawa		Poland	05-077
119	Novo Nordisk Investigational Site	Wroclaw		Poland	51-162
120	Novo Nordisk Investigational Site	Irkutsk		Russian Federation	664049
121	Novo Nordisk Investigational Site	Izhevsk		Russian Federation	426061
122	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
123	Novo Nordisk Investigational Site	Moscow		Russian Federation	127486
124	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630005
125	Novo Nordisk Investigational Site	Ryazan		Russian Federation	390026
126	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194044
127	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194156
128	Novo Nordisk Investigational Site	Saratov		Russian Federation	410028
129	Novo Nordisk Investigational Site	Saratov		Russian Federation	410031
130	Novo Nordisk Investigational Site	Voronezh		Russian Federation	394018
131	Novo Nordisk Investigational Site	Yoshkar-Ola		Russian Federation	424004
132	Novo Nordisk Investigational Site	Almeria		Spain	04009
133	Novo Nordisk Investigational Site	Castilleja Dela Cuesta Sevilla		Spain	41950
134	Novo Nordisk Investigational Site	Córdoba		Spain	14004
135	Novo Nordisk Investigational Site	Madrid		Spain	28006
136	Novo Nordisk Investigational Site	Madrid		Spain	28007
137	Novo Nordisk Investigational Site	Málaga		Spain	29009
138	Novo Nordisk Investigational Site	Sevilla		Spain	41009
139	Novo Nordisk Investigational Site	Göteborg		Sweden	413 45
140	Novo Nordisk Investigational Site	Uppsala		Sweden	751 85
141	Novo Nordisk Investigational Site	Kaoshiung		Taiwan	807
142	Novo Nordisk Investigational Site	Taichung		Taiwan	404
143	Novo Nordisk Investigational Site	Tainan City		Taiwan	704
144	Novo Nordisk Investigational Site	Taipei		Taiwan	100
145	Novo Nordisk Investigational Site	Taipei		Taiwan	112
146	Novo Nordisk Investigational Site	Taoyuan city		Taiwan	333
147	Novo Nordisk Investigational Site	Bangkok		Thailand	10400
148	Novo Nordisk Investigational Site	Chiang Mai		Thailand	50200
149	Novo Nordisk Investigational Site	Nakhon Ratchasima		Thailand	30000
150	Novo Nordisk Investigational Site	Pathumthani		Thailand	12120

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: Mar 31, 2022
• Last Verified: Mar 1, 2022

• 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: Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 31, 2022