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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
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
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
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
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
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)
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
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
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
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
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
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
Timepoint [10] 0 0
Week 0 - 109
Secondary outcome [11] 0 0
Incidence During the Trial in Other Treatment Outcomes: 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
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)
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)
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)
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
Sex
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
21/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2016
Sample size
Target
Accrual to date
Final
3297
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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Antequera
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Pozuelo de Alarcon
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Taiwan
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Tainan city
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Taiwan
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Taipei
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Taiwan
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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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Turkey
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Canakkale
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Denizli
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Istanbul
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Izmir
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Birmingham
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Sidcup
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Swansea
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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/study/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.
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.
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Public notes

Contacts
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Global Clinical Registry (GCR, 1452)
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Novo Nordisk A/S
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01720446