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Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6)

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ClinicalTrials.gov Identifier: NCT01720446
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : March 15, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE November 2, 2012
Results First Submitted Date  ICMJE December 14, 2017
Results First Posted Date  ICMJE March 15, 2018
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE February 21, 2013
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)		 Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 109) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)		 Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 109) ]
    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)
  • Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 109) ]
    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).
  • Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 109) ]
    Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, up to week 104 ]
    Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose [ Time Frame: Week 0, up to week 104 ]
    Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight [ Time Frame: Week 0, up to week 104 ]
    Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile [ Time Frame: Week 0, up to week 104 ]
    Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio [ Time Frame: Week 0, up to week 104 ]
    Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs [ Time Frame: Week 0, up to week 104 ]
    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).
  • Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events [ Time Frame: Week 0 - 109 ]
    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.
  • Incidence During the Trial in Other Treatment Outcomes: Adverse Events [ Time Frame: Weeks 0-109 ]
    Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
  • Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies [ Time Frame: Weeks 0-109 ]
    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.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO) [ Time Frame: Week 0, up to week 104 ]
    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.
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids) [ Time Frame: Week 0, up to week 104 ]
    Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
  • Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate) [ Time Frame: Week 0, up to week 104 ]
    Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • Time from randomisation to first occurrence of an expanded composite cardiovascular outcome [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ]
  • Time from randomisation to each individual component of the expanded composite cardiovascular outcome [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, up to week 143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose [ Time Frame: Week 0, up to week 143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight [ Time Frame: Week 0, up to week 143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: lipid profile [ Time Frame: Week 0, up to week 143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: urinary albumin to creatinine ratio [ Time Frame: Week 0, up to week 143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: vital signs [ Time Frame: Week 0, up to week 143 ]
  • Incidence during the treatment period in other treatment outcomes: hypoglycaemic events [ Time Frame: Week 0 - 143 ]
  • Incidence during the treatment period in other treatment outcomes: adverse events [ Time Frame: Weeks 0-143 ]
  • Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies [ Time Frame: Weeks 0-143 ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO) [ Time Frame: Week 0, up to week 143 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: 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)
  • Drug: 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)
  • Drug: placebo
    Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Study Arms  ICMJE
  • Experimental: Semaglutide 0.5 mg
    Intervention: Drug: semaglutide
  • Experimental: Semaglutide 1.0 mg
    Intervention: Drug: semaglutide
  • Placebo Comparator: Semaglutide placebo 0.5 mg
    Intervention: Drug: placebo
  • Placebo Comparator: Semaglutide placebo 1.0 mg
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)		 3297
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2012)		 3260
Actual Study Completion Date  ICMJE March 15, 2016
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Algeria,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Denmark,   Germany,   India,   Israel,   Italy,   Malaysia,   Mexico,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01720446
Other Study ID Numbers  ICMJE NN9535-3744
2012-002839-28 ( EudraCT Number )
U1111-1131-7227 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Public Access to Clinical Trials, Novo Nordisk A/S
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP