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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01720446
Registration number
NCT01720446
Ethics application status
Date submitted
29/10/2012
Date registered
2/11/2012
Date last updated
27/06/2019
Titles & IDs
Public title
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
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Scientific title
A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
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Secondary ID [1]
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0
2012-002839-28
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Secondary ID [2]
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NN9535-3744
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Universal Trial Number (UTN)
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Trial acronym
SUSTAIN™ 6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - semaglutide
Treatment: Drugs - semaglutide
Treatment: Drugs - placebo
Experimental: Semaglutide 0.5 mg -
Experimental: Semaglutide 1.0 mg -
Placebo comparator: Semaglutide placebo 0.5 mg -
Placebo comparator: Semaglutide placebo 1.0 mg -
Treatment: Drugs: semaglutide
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Treatment: Drugs: semaglutide
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Treatment: Drugs: placebo
Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
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Assessment method [1]
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Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
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Timepoint [1]
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Time from randomisation up to end of follow-up (scheduled at week 109)
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Secondary outcome [1]
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Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
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Assessment method [1]
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Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation \[coronary and peripheral\], unstable angina requiring hospitalisation or hospitalisation for heart failure)
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Timepoint [1]
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Time from randomisation up to end of follow-up (scheduled at week 109)
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Secondary outcome [2]
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Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
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Assessment method [2]
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Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation \[coronary and peripheral\], unstable angina requiring hospitalisation or hospitalisation for heart failure).
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Timepoint [2]
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Time from randomisation up to end of follow-up (scheduled at week 109)
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Secondary outcome [3]
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Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
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Assessment method [3]
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Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
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Timepoint [3]
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Time from randomisation up to end of follow-up (scheduled at week 109)
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Secondary outcome [4]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
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Assessment method [4]
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Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
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Timepoint [4]
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Week 0, up to week 104
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Secondary outcome [5]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
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Assessment method [5]
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Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
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Timepoint [5]
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0
Week 0, up to week 104
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Secondary outcome [6]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
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Assessment method [6]
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Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
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Timepoint [6]
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0
Week 0, up to week 104
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Secondary outcome [7]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
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Assessment method [7]
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Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
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Timepoint [7]
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Week 0, up to week 104
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Secondary outcome [8]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
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Assessment method [8]
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Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
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Timepoint [8]
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0
Week 0, up to week 104
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Secondary outcome [9]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
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Assessment method [9]
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Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).
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Timepoint [9]
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Week 0, up to week 104
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Secondary outcome [10]
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Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
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Assessment method [10]
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Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
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Timepoint [10]
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Week 0 - 109
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Secondary outcome [11]
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Incidence During the Trial in Other Treatment Outcomes: Adverse Events
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Assessment method [11]
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Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
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Timepoint [11]
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Weeks 0-109
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Secondary outcome [12]
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Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
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Assessment method [12]
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The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.
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Timepoint [12]
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Weeks 0-109
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Secondary outcome [13]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
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Assessment method [13]
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Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.
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Timepoint [13]
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Week 0, up to week 104
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Secondary outcome [14]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
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Assessment method [14]
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Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
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Timepoint [14]
0
0
Week 0, up to week 104
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Secondary outcome [15]
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Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
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Assessment method [15]
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Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
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Timepoint [15]
0
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Week 0, up to week 104
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Eligibility
Key inclusion criteria
- Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/03/2016
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Sample size
Target
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Accrual to date
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Final
3297
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Blacktown
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Ipswich
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Recruitment hospital [4]
0
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Novo Nordisk Investigational Site - Keswick
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Oaklands Park
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Recruitment hospital [6]
0
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Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [7]
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Novo Nordisk Investigational Site - Fitzroy
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Recruitment hospital [8]
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Novo Nordisk Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4305 - Ipswich
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Recruitment postcode(s) [4]
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5035 - Keswick
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Recruitment postcode(s) [5]
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5046 - Oaklands Park
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3065 - Fitzroy
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Recruitment postcode(s) [8]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Indiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Kansas
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kentucky
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Country [12]
0
0
United States of America
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State/province [12]
0
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Louisiana
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Country [13]
0
0
United States of America
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State/province [13]
0
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Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
0
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Michigan
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Country [15]
0
0
United States of America
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State/province [15]
0
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Missouri
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Country [16]
0
0
United States of America
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State/province [16]
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Nebraska
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Country [17]
0
0
United States of America
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State/province [17]
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New Hampshire
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Country [18]
0
0
United States of America
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State/province [18]
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New Jersey
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Country [19]
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United States of America
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State/province [19]
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New York
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Country [20]
0
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United States of America
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State/province [20]
0
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North Carolina
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Country [21]
0
0
United States of America
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State/province [21]
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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0
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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State/province [27]
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Utah
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Country [28]
0
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United States of America
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State/province [28]
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Vermont
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Country [29]
0
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United States of America
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State/province [29]
0
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Virginia
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0
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United States of America
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State/province [30]
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Washington
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Country [31]
0
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United States of America
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State/province [31]
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Wisconsin
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0
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Algeria
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State/province [32]
0
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Annaba
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Country [33]
0
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Algeria
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State/province [33]
0
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Oran
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Country [34]
0
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Algeria
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State/province [34]
0
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Setif
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Country [35]
0
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Algeria
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State/province [35]
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Tizi Ouzou
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0
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Argentina
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State/province [36]
0
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Caba
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Country [37]
0
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Argentina
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State/province [37]
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Cordoba
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0
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Argentina
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State/province [38]
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Mar del Plata
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0
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Argentina
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Morón
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0
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Brazil
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0
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Parana
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0
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Brazil
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Para
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0
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Brazil
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Sao Paulo
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Brazil
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State/province [43]
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Porto Alegre
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Country [44]
0
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Bulgaria
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State/province [44]
0
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Pleven
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0
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Bulgaria
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State/province [45]
0
0
Sofia
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0
0
Bulgaria
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State/province [46]
0
0
Varna
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0
0
Canada
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0
0
Alberta
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Country [48]
0
0
Canada
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State/province [48]
0
0
Manitoba
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Country [49]
0
0
Canada
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State/province [49]
0
0
Newfoundland and Labrador
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Country [50]
0
0
Canada
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State/province [50]
0
0
Ontario
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Country [51]
0
0
Canada
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State/province [51]
0
0
Quebec
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Country [52]
0
0
Denmark
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State/province [52]
0
0
Aarhus C
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Country [53]
0
0
Denmark
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State/province [53]
0
0
Gentofte
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0
0
Denmark
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State/province [54]
0
0
Hellerup
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0
0
Denmark
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State/province [55]
0
0
Hvidovre
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Country [56]
0
0
Denmark
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State/province [56]
0
0
Odense
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Country [57]
0
0
Germany
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State/province [57]
0
0
Elsterwerda
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Country [58]
0
0
Germany
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State/province [58]
0
0
Essen
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Country [59]
0
0
Germany
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State/province [59]
0
0
Falkensee
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Country [60]
0
0
Germany
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State/province [60]
0
0
Freiburg
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0
0
Germany
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State/province [61]
0
0
Hamburg
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Country [62]
0
0
Germany
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State/province [62]
0
0
Münster
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Country [63]
0
0
Germany
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State/province [63]
0
0
Oldenburg
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Country [64]
0
0
Germany
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State/province [64]
0
0
Saint Ingbert
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Country [65]
0
0
India
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State/province [65]
0
0
Andhra Pradesh
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Country [66]
0
0
India
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State/province [66]
0
0
Karnataka
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Country [67]
0
0
India
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State/province [67]
0
0
Kerala
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Country [68]
0
0
India
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State/province [68]
0
0
Maharashtra
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Country [69]
0
0
India
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State/province [69]
0
0
New Delhi
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Country [70]
0
0
India
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State/province [70]
0
0
Punjab
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Country [71]
0
0
India
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State/province [71]
0
0
Tamil Nadu
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Country [72]
0
0
India
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State/province [72]
0
0
West Bengal
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Country [73]
0
0
India
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State/province [73]
0
0
Pune
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Country [74]
0
0
Israel
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State/province [74]
0
0
Holon
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Country [75]
0
0
Israel
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State/province [75]
0
0
Jerusalem
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Country [76]
0
0
Israel
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State/province [76]
0
0
Nahariya
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Country [77]
0
0
Israel
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State/province [77]
0
0
Petah-Tikva
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Country [78]
0
0
Israel
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State/province [78]
0
0
Tel Hashomer
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Country [79]
0
0
Israel
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State/province [79]
0
0
Tel-Aviv
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Country [80]
0
0
Italy
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State/province [80]
0
0
Bergamo
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Country [81]
0
0
Italy
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State/province [81]
0
0
Chieti
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Country [82]
0
0
Italy
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State/province [82]
0
0
Olbia
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Country [83]
0
0
Italy
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State/province [83]
0
0
Padova
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Country [84]
0
0
Italy
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State/province [84]
0
0
Primo Piano Palazzina Ambulato
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Country [85]
0
0
Italy
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State/province [85]
0
0
Siena
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Country [86]
0
0
Malaysia
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State/province [86]
0
0
Kota Samarahan
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Country [87]
0
0
Malaysia
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State/province [87]
0
0
Kuala Lumpur
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Country [88]
0
0
Malaysia
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State/province [88]
0
0
Kuching
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Country [89]
0
0
Malaysia
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State/province [89]
0
0
Melaka
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Funding & Sponsors
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Novo Nordisk A/S
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Summary
Brief summary
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.
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Trial website
https://clinicaltrials.gov/study/NCT01720446
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Trial related presentations / publications
Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15. Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8. Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15. Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8. Strain WD, Frenkel O, James MA, Leiter LA, Rasmussen S, Rothwell PM, Sejersten Ripa M, Truelsen TC, Husain M. Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6. Stroke. 2022 Sep;53(9):2749-2757. doi: 10.1161/STROKEAHA.121.037775. Epub 2022 May 18. Husain M, Consoli A, De Remigis A, Pettersson Meyer AS, Rasmussen S, Bain S. Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6. Cardiovasc Diabetol. 2022 Apr 28;21(1):64. doi: 10.1186/s12933-022-01489-6. Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11. Verma S, Fainberg U, Husain M, Rasmussen S, Ryden L, Ripa MS, Buse JB. Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide. Diabetes Obes Metab. 2021 Jul;23(7):1677-1680. doi: 10.1111/dom.14360. Epub 2021 Mar 18. Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4. Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4. Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12. Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3. Jodar E, Michelsen M, Polonsky W, Rea R, Sandberg A, Vilsboll T, Warren M, Harring S, Ziegler U, Bain S. Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6). Diabetes Obes Metab. 2020 Aug;22(8):1339-1347. doi: 10.1111/dom.14039. Epub 2020 Apr 27. Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5. DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072. Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
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Public notes
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Contacts
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Global Clinical Registry (GCR, 1452)
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Novo Nordisk A/S
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What supporting documents are/will be available?
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Results publications and other study-related documents
Type
Citations or Other Details
Journal
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jod...
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Journal
Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthew...
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Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J,...
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Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, J...
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Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S,...
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Results are available at
https://clinicaltrials.gov/study/NCT01720446
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