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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914326
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date July 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03914326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • 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
  • Time to occurrence of CV death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months
  • 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
  • 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
  • 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
  • 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
  • Time to occurrence of all-cause death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months
  • 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
  • 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
  • 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
  • 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
  • Time to first occurrence of coronary revascularisation [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months
  • 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
  • Time to occurrence of renal death [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From randomisation (week 0) to 2 years ]
    Percent points
  • Change in body weight [ Time Frame: From randomisation (week 0) to 2 years ]
    Kilograms
  • Number of severe hypoglycaemic episodes [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Number of events
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
Official Title  ICMJE Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
  • Drug: Placebo (semaglutide)
    Placebo tablets to be taken with water at the same time every morning in a fasting state
Study Arms  ICMJE
  • Experimental: Oral semaglutide
    One tablet daily for 3.5 to 5 years
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo
    One tablet daily for 3.5 to 5 years
    Intervention: Drug: Placebo (semaglutide)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
9642
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 29, 2024
Estimated Primary Completion Date July 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com
Listed Location Countries  ICMJE Algeria,   Argentina,   Austria,   Belgium,   Brazil,   Canada,   China,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914326
Other Study ID Numbers  ICMJE EX9924-4473
2018-003141-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1218-5368 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP