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

Primary Purpose

Diabetes Mellitus, Type 2, Peripheral Arterial Disease

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo (semaglutide)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo (semaglutide)

Arm Description

Semaglutide given in addition to standard-of-care treatment

Placebo given in addition to standard-of-care treatment

Outcomes

Primary Outcome Measures

Change in maximum walking distance on a constant load treadmill test

Ratio to baseline

Secondary Outcome Measures

Follow-up change in maximum walking distance on a constant load treadmill test

Ratio to baseline

Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score

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

Change in pain-free walking distance on a constant load treadmill test

Ratio to baseline

Follow-up change in pain-free walking distance on a constant load treadmill test

Ratio to baseline

Change in glycosylated haemoglobin (HbA1c)

Percentage point

Change in body weight

Kilogram

Change in systolic blood pressure

mmHg

Change in total cholesterol

Ratio to baseline

Change in Low-density lipoprotein (LDL)- cholesterol

Ratio to baseline

Change in High density lipoprotein (HDL)- cholesterol

Ratio to baseline

Change in triglycerides

Ratio to baseline

Change in ankle-brachial index (ABI)

Ratio

Change in toe-brachial index (TBI)

Ratio

Change in Walking Impairment Questionnaire (WIQ) global score

Percentage point

Change in Short Form 36 (SF-36) physical functioning domain

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

Full Information

NCT ID

NCT04560998

First Posted

September 18, 2020

Last Updated

September 19, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04560998

Brief Title

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

Acronym

STRIDE

Official Title

Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

June 5, 2024 (Anticipated)

Study Completion Date

July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Semaglutide given in addition to standard-of-care treatment

Arm Title

Placebo (semaglutide)

Arm Type

Placebo Comparator

Arm Description

Placebo given in addition to standard-of-care treatment

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in maximum walking distance on a constant load treadmill test

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of treatment (week 52)

Secondary Outcome Measure Information:

Title

Follow-up change in maximum walking distance on a constant load treadmill test

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of follow-up (week 57)

Title

Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score

Description

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in pain-free walking distance on a constant load treadmill test

Description

Ratio to baseline

Time Frame

Change in pain-free walking distance on a constant load treadmill test

Title

Follow-up change in pain-free walking distance on a constant load treadmill test

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of follow-up (week 57)

Title

Change in glycosylated haemoglobin (HbA1c)

Description

Percentage point

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in body weight

Description

Kilogram

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in systolic blood pressure

Description

mmHg

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in total cholesterol

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in Low-density lipoprotein (LDL)- cholesterol

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in High density lipoprotein (HDL)- cholesterol

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in triglycerides

Description

Ratio to baseline

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in ankle-brachial index (ABI)

Description

Ratio

Time Frame

From screening (week -2) to end of treatment (week 52)

Title

Change in toe-brachial index (TBI)

Description

Ratio

Time Frame

From screening (week -2) to end of treatment (week 52)

Title

Change in Walking Impairment Questionnaire (WIQ) global score

Description

Percentage point

Time Frame

From baseline (week 0) to end of treatment (week 52)

Title

Change in Short Form 36 (SF-36) physical functioning domain

Description

Time Frame

From baseline (week 0) to end of treatment (week 52)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90010

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Martinez

State/Province

Georgia

ZIP/Postal Code

30907

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Munster

State/Province

Indiana

ZIP/Postal Code

46321

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bogalusa

State/Province

Louisiana

ZIP/Postal Code

70427

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Camp Hill

State/Province

Pennsylvania

ZIP/Postal Code

17011

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430-8183

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601-3834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

North York

State/Province

Ontario

ZIP/Postal Code

M6B 3H7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brossard

State/Province

Quebec

ZIP/Postal Code

J4Z 2K9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 7K9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 3Y7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

QC H1T 1C8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1L 3L5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Tianjin

ZIP/Postal Code

300121

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hodonin

ZIP/Postal Code

695 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Jaroměř

ZIP/Postal Code

55101

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Ostrava Dubina

ZIP/Postal Code

700 30

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Plzen

ZIP/Postal Code

30100

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

København Ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01277

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Lübeck

ZIP/Postal Code

23562

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Nürnberg

ZIP/Postal Code

90402

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-14233

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-15123

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Chios

ZIP/Postal Code

GR82100

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Haidari-Athens

ZIP/Postal Code

GR-12462

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Lamia

ZIP/Postal Code

GR35100

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR 54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57010

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Szeged

State/Province

Csongrád-Csanád

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Zalaegerszeg

State/Province

Zala Megye

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Surat

State/Province

Gujarat

ZIP/Postal Code

395001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bikaner

State/Province

Rajasthan

ZIP/Postal Code

334003

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderbad

State/Province

Telengana

ZIP/Postal Code

500 012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chiba-shi, Chiba

ZIP/Postal Code

260-0804

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chiba

ZIP/Postal Code

271-0077

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hyogo

ZIP/Postal Code

654-0026

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hyogo

ZIP/Postal Code

665-0873

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki,

ZIP/Postal Code

331-0133

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Omihachiman-shi, Siga

ZIP/Postal Code

523-0082

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

559-0012

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saitama

ZIP/Postal Code

360-0197

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shiga

ZIP/Postal Code

525-8585

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

192-0918

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Kota Bharu

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Sungai Buloh

State/Province

Selangor

ZIP/Postal Code

47000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

50400

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Kuantan

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Sabah

ZIP/Postal Code

88300

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Kristiansand

ZIP/Postal Code

4615

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0586

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

31-261

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Krakow

ZIP/Postal Code

31-271

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-111

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

71-531

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

05-077

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Castilleja Dela Cuesta Sevilla

ZIP/Postal Code

41950

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Kaoshiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taichung City

ZIP/Postal Code

433

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Tainan City

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taoyuan city

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Muang

State/Province

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Hat Yai

State/Province

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Nakhon Ratchasima

ZIP/Postal Code

30000

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Pathumthani

ZIP/Postal Code

12120

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

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

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

Diabetes Mellitus, Type 2, Peripheral Arterial Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial