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Completed

NCT Number: NCT01720446

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

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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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Annaba, Algeria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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)

Placebo

Drug

Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: SUSTAIN™ 6

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2012
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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