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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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)
Secondary ID [1] 0 0
2012-002839-28
Secondary ID [2] 0 0
NN9535-3744
Universal Trial Number (UTN)
Trial acronym
SUSTAIN™ 6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke - 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.
Timepoint [1] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [1] 0 0
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome - 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)
Timepoint [1] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [2] 0 0
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome - 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).
Timepoint [2] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [3] 0 0
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke - Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
Timepoint [3] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [4] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c) - Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
Timepoint [4] 0 0
Week 0, up to week 104
Secondary outcome [5] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose - Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
Timepoint [5] 0 0
Week 0, up to week 104
Secondary outcome [6] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight - Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
Timepoint [6] 0 0
Week 0, up to week 104
Secondary outcome [7] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile - Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
Timepoint [7] 0 0
Week 0, up to week 104
Secondary outcome [8] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio - Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
Timepoint [8] 0 0
Week 0, up to week 104
Secondary outcome [9] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs - 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).
Timepoint [9] 0 0
Week 0, up to week 104
Secondary outcome [10] 0 0
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events - 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.
Timepoint [10] 0 0
Week 0 - 109
Secondary outcome [11] 0 0
Incidence During the Trial in Other Treatment Outcomes: Adverse Events - Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
Timepoint [11] 0 0
Weeks 0-109
Secondary outcome [12] 0 0
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies - 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.
Timepoint [12] 0 0
Weeks 0-109
Secondary outcome [13] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO) - 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.
Timepoint [13] 0 0
Week 0, up to week 104
Secondary outcome [14] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids) - Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
Timepoint [14] 0 0
Week 0, up to week 104
Secondary outcome [15] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate) - Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
Timepoint [15] 0 0
Week 0, up to week 104

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
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Oaklands Park
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
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Taoyuan
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Thailand
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Bangkok
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Turkey
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Ankara
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Antalya
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Canakkale
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Denizli
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Istanbul
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Izmir
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United Kingdom
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Aberdeen
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Birmingham
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Leeds
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Liverpool
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Northwood
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United Kingdom
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Sidcup
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Swansea
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United Kingdom
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Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01720446
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.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications