A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03914326 ↗Summary
Linked Publications (5)
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Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes.
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Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial.
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Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction.
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Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes: A Secondary Analysis of the SOUL Randomized Clinical Trial.
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Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants From Randomization 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 |
579; 668 | 0.0028 sig |
| SECONDARY Number of Participants From Randomization to First Occurrence of CV Death;Renal Death;Onset of Persistent≥50% Reduction in eGFR(CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73m^2;Initiation of Chronic Renal Replacement Therapy |
403; 435 | — |
| SECONDARY Number of Participants From Randomization to Time of Occurrence of CV Death |
301; 320 | — |
| SECONDARY Number of Participants From Randomization to First Occurrence of Major Adverse Limb Events (MALE), a Composite Endpoint Consisting of: Acute Limb Ischemia Hospitalisation/Chronic Limb Ischemia Hospitalisation |
71; 99 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of an Expanded MACE Composite Endpoint Consisting of: CV Death/Non-fatal Myocardial Infarction/ Non-fatal Stroke/Coronary Revascularisation/Unstable Angina Pectoris Requiring Hospitalisation |
670; 777 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of a Composite Endpoint Consisting of : All-cause Death/ Non-fatal MI/ Non-fatal Stroke |
779; 902 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of a Composite Heart Failure Endpoint Consisting of: CV Death/Heart Failure Requiring Hospitalisation/Urgent Heart Failure Visit |
405; 443 | — |
| SECONDARY Number of Participants From Randomization to First Occurrence of CKD Endpoint:Renal Death;Onset of Persistent≥50% Reduction in eGFR (CKD-EPI);Onset of Persistent eGFR(CKD-EPI)<15 mL/Min/1.73 m^2;Initiation of Chronic Renal Replacement Therapy |
112; 129 | — |
| SECONDARY Number of Participants From Randomisation to Time to Occurrence of All-cause Death |
528; 577 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Non-fatal Myocardial Infarction (MI) |
191; 253 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Non-fatal Stroke |
144; 161 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Heart Failure Requiring Hospitalisation or Urgent Heart Failure Visit |
146; 167 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Coronary Revascularisation |
200; 263 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Unstable Angina Requiring Hospitalisation |
74; 80 | — |
| SECONDARY Number of Participants From Randomisation to Time to Occurrence of Renal Death |
1; 7 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Onset of Persistent 50% or More Reduction in eGFR |
71; 86 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Onset of Persistent eGFR (CKD-EPI) Below 15 mL/Min/1.73 m^2 |
23; 33 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Initiation of Chronic Renal Replacement Therapy (Dialysis or Kidney Transplantation) |
40; 48 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Acute Limb Ischemia |
16; 17 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of Chronic Limb Ischemia Hospitalisation |
63; 88 | — |
| SECONDARY Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) |
-1.67; -2.06 | — |
| SECONDARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) |
-0.71; -0.15 | — |
| SECONDARY Change From Baseline in Body Weight |
-4.21; -1.28 | — |
| SECONDARY Number of Severe Hypoglycaemic Episodes |
88; 121 | — |
| SECONDARY Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode |
76; 84 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03914326) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.