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

  • STATUS
    Recruiting
  • End date
    Jul 29, 2024
  • participants needed
    9642
  • sponsor
    Novo Nordisk A/S
Updated on 26 November 2020
Investigator
Novo Nordisk
Primary Contact
Novo Nordisk Investigational Site (0.0 mi away) Contact
+550 other location
stroke
chronic disease
semaglutide

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.

Details
Treatment Placebo, semaglutide, Placebo (semaglutide)
Clinical Study IdentifierNCT03914326
SponsorNovo Nordisk A/S
Last Modified on26 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or NIDDM?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or NIDDM or Diabetes Mellitus, Type 2 or type 2 diabetes mellitus or diabetes type 2 or type 2 diabetes or type...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or diabetes type 2 or Diabetes Mellitus Type 2 or type 2 diabetes or NIDDM or type 2 diabetes mellitus or noninsulin-depende...?
Do you have any of these conditions: type 2 diabetes mellitus or type ii diabetes or Diabetes Mellitus Type 2 or type 2 diabetes or diabetes type 2 or noninsulin-dependent diabetes mellit...?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or diabetes type 2 or NIDDM or type ii diabetes or Diabetes Mellitus, Type 2 or type 2 diabetes or Diabetes Mel...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or diabetes type 2 or type 2 diabetes mellitus or type 2 diabetes or NIDDM or type ii diabetes o...?
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)
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
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