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Study · Randomized controlled trial · n = 3,297 · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T

The New England journal of medicine15 Sept 2016Cited by 5,002 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes at high cardiovascular risk, semaglutide lowered the rate of the primary composite cardiovascular outcome versus placebo, confirming noninferiority.

    In plain wordsIn adults with type 2 diabetes at high heart risk, fewer people on semaglutide than on placebo had a heart attack, stroke or heart-related death.

    Outcome
    DecreaseFirst cardiovascular death, nonfatal myocardial infarction or nonfatal stroke
    Study

    n = 3,297

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Measurements

    Hazard ratio
    0.74 ratio
    primary outcome, semaglutide vs placebo

    Source sentences

    Summary
    The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.58 to 0.95; P<0.001 for noninferiority).
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes at high cardiovascular risk, semaglutide had no significant effect on nonfatal myocardial infarction versus placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, semaglutide did not significantly change non-deadly heart attacks compared with placebo.

    Outcome
    No significant changeNonfatal myocardial infarction
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Measurements

    Hazard ratio
    0.74 ratio
    nonfatal MI, semaglutide vs placebo

    Source sentences

    Summary
    Nonfatal myocardial infarction occurred in 2.9% of the patients receiving semaglutide and in 3.9% of those receiving placebo (hazard ratio, 0.74; 95% CI, 0.51 to 1.08; P=0.12
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes at high cardiovascular risk, semaglutide lowered the rate of nonfatal stroke versus placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, fewer people on semaglutide than on placebo had a non-deadly stroke.

    Outcome
    DecreaseNonfatal stroke
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Measurements

    Hazard ratio
    0.61 ratio
    nonfatal stroke, semaglutide vs placebo

    Source sentences

    Summary
    nonfatal stroke occurred in 1.6% and 2.7%, respectively (hazard ratio, 0.61; 95% CI, 0.38 to 0.99; P=0.04
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes at high cardiovascular risk, rates of death from cardiovascular causes were similar with semaglutide and placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, heart-related deaths were similar with semaglutide and with placebo.

    Outcome
    No significant changeDeath from cardiovascular causes
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Rates of death from cardiovascular causes were similar in the two groups.
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes at high cardiovascular risk, rates of new or worsening nephropathy were lower with semaglutide than with placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, new or worsening kidney disease was less frequent with semaglutide than with placebo.

    Outcome
    DecreaseNew or worsening nephropathy
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Rates of new or worsening nephropathy were lower in the semaglutide group
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes at high cardiovascular risk, retinopathy complications were significantly more frequent with semaglutide than with placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, eye complications of retinopathy were more frequent with semaglutide than with placebo.

    Outcome
    IncreaseRetinopathy complications
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Adverse events · Eye
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Measurements

    Hazard ratio
    1.76 ratio
    retinopathy complications, semaglutide vs placebo

    Source sentences

    Summary
    rates of retinopathy complications (vitreous hemorrhage, blindness, or conditions requiring treatment with an intravitreal agent or photocoagulation) were significantly higher (hazard ratio, 1.76; 95% CI, 1.11 to 2.78; P=0.02
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes at high cardiovascular risk, fewer serious adverse events occurred with semaglutide than with placebo.

    In plain wordsIn adults with type 2 diabetes at high heart risk, fewer serious side effects occurred with semaglutide than with placebo.

    Outcome
    DecreaseSerious adverse events
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Fewer serious adverse events occurred in the semaglutide group
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes at high cardiovascular risk, more patients on semaglutide than on placebo discontinued treatment because of adverse events, mainly gastrointestinal.

    In plain wordsIn adults with type 2 diabetes at high heart risk, more people on semaglutide than on placebo stopped treatment for side effects, mainly gut ones.

    Outcome
    IncreaseDiscontinuation due to adverse events
    Study

    n = 3,297

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 mg or 1.0 mg once weekly · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    although more patients discontinued treatment because of adverse events, mainly gastrointestinal.
    1 context sentence
    Summary · context
    We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials12

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

12 trials · 6 ongoing · 2 not yet recruiting · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

RecruitingPhase 2/3NCT07284511

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

McGill University Health Centre/Research Institute of the McGill University Health Centren = 10519 May 2026 to est. Jan 2029

Type 1 Diabetes · Type 1 Diabetes Mellitus · T1D · T1DM · T1DM - Type 1 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 27 May 2026
Not yet recruitingPhase 3NCT07090343

Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Leiden University Medical Centern = 826est. 1 Apr 2026 to est. 1 Apr 2031

Aortic Stenosis · Heart Failure

Trial pageClinicalTrials.govUpdated 29 Jul 2025
RecruitingNot applicableNCT07065383

Rebalancing the Fat Content of the Heart and Muscles

University of Aberdeenn = 601 Aug 2025 to est. 31 Jul 2028

Diabetes Mellitus Type 2

Trial pageClinicalTrials.govUpdated 30 Apr 2026
Not yet recruitingPhase 3NCT07030621

Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial

RenJi Hospitaln = 436est. 1 Jul 2025 to est. 31 Jan 2028

Acute Ischemic Stroke

Trial pageClinicalTrials.govUpdated 22 Jun 2025
RecruitingPhase 3NCT06894784

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

McGill University Health Centre/Research Institute of the McGill University Health Centren = 36est. Apr 2025 to est. Jan 2027

Diabetes Type 1

Trial pageClinicalTrials.govUpdated 30 Mar 2025
CompletedPhase not statedNCT07190144

Coronary Flow Reserve Changes After Semaglutide Treatment

Ekrem Bilal Karaayvazn = 1227 Jan 2025 to 1 Aug 2025

The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients · Obesity &Amp; Overweight

Trial pageClinicalTrials.govUpdated 24 Sept 2025
Enrolling by invitationEarly phase 1NCT07092605

Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures

AgelessRxn = 1501 Nov 2024 to est. 1 Dec 2025

Longevity · Quality of Life · Mood · Inflammation · Immune Health · Pain Management · Weight Management · Alertness

Trial pageClinicalTrials.govUpdated 30 Jul 2025
RecruitingPhase 4NCT06606821

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

Tina Vilsbølln = 1241 Oct 2024 to est. 1 Aug 2028

Coronary Artery Disease · Coronary Microvascular Dysfunction · Overweight or Obesity · Stable Angina Pectoris · Chronic Coronary Artery Disease · Atherosclerosis Cardiovascular Disease

Trial pageClinicalTrials.govUpdated 22 May 2025
RecruitingPhase 2NCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

AdventHealth Translational Research Instituten = 475 Oct 2023 to est. 30 Jul 2028

Diabetes Mellitus, Type 1 · Endothelial Dysfunction

Trial pageClinicalTrials.govUpdated 15 Oct 2026
Status unknownPhase 4NCT05870462

Semaglutide and Vascular Regeneration

Canadian Medical and Surgical Knowledge Translation Research Groupn = 10029 Apr 2023 to est. Dec 2024

Atherosclerosis · Cardiovascular Diseases · Diabetes Mellitus, Type 2 · Obesity

Trial pageClinicalTrials.govUpdated 25 Jul 2023
Status unknownPhase 4NCT04122716

Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet

Signe Torekovn = 215Sept 2016 to est. Nov 2021

Obesity

CompletedPhase 3Results postedNCT01720446

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 3,29721 Feb 2013 to 15 Mar 2016

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 27 Jun 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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