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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : February 21, 2013
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : March 15, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide 0.5 mg 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)
Experimental: Semaglutide 1.0 mg 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)
Placebo Comparator: Semaglutide placebo 0.5 mg 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).
Placebo Comparator: Semaglutide placebo 1.0 mg 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720446


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720446    
Other Study ID Numbers: NN9535-3744
2012-002839-28 ( EudraCT Number )
U1111-1131-7227 ( Other Identifier: WHO )
First Posted: November 2, 2012    Key Record Dates
Results First Posted: March 15, 2018
Last Update Posted: June 27, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs