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A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL)

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ClinicalTrials.gov Identifier: NCT03914326
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9642 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: Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : July 29, 2024
Estimated Study Completion Date : July 29, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral semaglutide
One tablet daily for 3.5 to 5 years
 Drug: Semaglutide
Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
Placebo Comparator: Placebo
One tablet daily for 3.5 to 5 years
 Drug: Placebo (semaglutide)
Placebo tablets to be taken with water at the same time every morning in a fasting state


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death/non-fatal myocardial infarction/non-fatal stroke [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven) ]
    Months


Secondary Outcome Measures :
  1. Time to first occurrence of a composite endpoint [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]

    Time to first occurrence of a composite endpoint consisting of: CV death/renal death/onset of persistent 50% or more reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (compared with baseline)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation).

    Unit of assessment: Months


  2. Time to occurrence of CV death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  3. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  4. Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina requiring hospitalisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  5. Time to first occurrence of a composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  6. Time to first occurrence of a composite CKD endpoint [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]

    Time to first occurrence of a composite CKD endpoint consisting of: renal death/onset of persistent 50% or more reduction in eGFR (CKD-EPI)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation).

    Unit of assessment: Months


  7. Time to occurrence of all-cause death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  8. Time to first occurrence of non-fatal myocardial infarction (MI) [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  9. Time to first occurrence of non-fatal stroke [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  10. Time to first occurrence of heart failure requiring hospitalisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  11. Time to first occurrence of urgent heart failure visit [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  12. Time to first occurrence of coronary revascularisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  13. Time to first occurrence of unstable angina requiring hospitalisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  14. Time to occurrence of renal death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  15. Time to first occurrence of onset of persistent 50% or more reduction in eGFR [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  16. Time to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2 [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  17. Time to first occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  18. Time to first occurrence of a composite endpoint consisting of: all-cause death/non-fatal myocardial infarction/non-fatal stroke [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  19. Time to first occurrence of acute limb ischemia [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  20. Time to first occurrence of chronic limb ischemia [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

  21. Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    ml/min/1.73 m^2 per year

  22. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From randomisation (week 0) to 2 years ]
    Percent points

  23. Change in body weight [ Time Frame: From randomisation (week 0) to 2 years ]
    Kilograms

  24. Number of severe hypoglycaemic episodes [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Number of events

  25. Time to first occurrence of a severe hypoglycaemic episode [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age equal to or above 50 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)

  • At least one of the below conditions (a-d):

    a) Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2 (based on medical records using latest available and no more than 6 months old assessment)

Exclusion Criteria:

  • Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Heart failure presently classified as being in New York Heart Association Class IV
  • Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914326


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03914326    
Other Study ID Numbers: EX9924-4473
2018-003141-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1218-5368 ( Other Identifier: World Health Organization (WHO) )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases