Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name SUSTAIN™ 6
United States, Algeria, Argentina, Australia, Brazil, Bulgaria, Canada, Denmark, Germany, India, Israel, Italy, Malaysia, Mexico, Poland, Russia, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Semaglutide 0.5 mg
Experimental
Semaglutide 1.0 mg
Placebo comparator
Semaglutide placebo 0.5 mg
Placebo comparator
Semaglutide placebo 1.0 mg
Outcomes the sponsor listed as primary.
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.
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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide | 6.6 |
| Placebo | 8.9 |
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide | 12.1 |
| Placebo | 16.0 |
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide | 1.6 |
| Placebo | 1.9 |
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide | 7.4 |
| Placebo | 9.6 |
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.09 | 0.05 |
| Semaglutide 1.0 mg | -1.41 | 0.05 |
| Placebo 0.5 mg | -0.44 | 0.05 |
| Placebo 1.0 mg | -0.36 | 0.05 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.75 | 0.12 |
| Semaglutide 1.0 mg | -2.11 | 0.12 |
| Placebo 0.5 mg | -1.02 | 0.12 |
| Placebo 1.0 mg | -0.88 | 0.12 |
| Group | Value (kg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -3.57 | 0.21 |
| Semaglutide 1.0 mg | -4.88 | 0.22 |
| Placebo | -0.62 | 0.15 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | 0.97 | 0.01 |
| Semaglutide 1.0 mg | 0.97 | 0.01 |
| Placebo 0.5 mg | 1.00 | 0.01 |
| Placebo 1.0 mg | 0.99 | 0.01 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5 mgSubjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks. | – | 289 / 826 | 573 / 826 |
| Semaglutide 1.0 mgSubjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks. | – | 276 / 822 | 587 / 822 |
| Placebo 0.5 mgSubjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks. | – | 329 / 824 | 547 / 824 |
| Placebo 1.0 mgSubjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks. | – | 298 / 825 | 524 / 825 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
9 studies on this page
Indexing hint: Meta-analysis (pooled) · 2025
Natale et al. 2025The Cochrane database of systematic reviewscited by 8
PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952
Indexing hint: Meta-analysis (pooled) · 2022
Husain et al. 2022Cardiovascular diabetologycited by 16
PMID 35484580PMC9052629DOI 10.1186/s12933-022-01489-6PUB-35484580
Indexing hint: Randomized controlled trial · 2022
Strain et al. 2022Strokecited by 62
PMID 35582947PMC9389936DOI 10.1161/strokeaha.121.037775PUB-35582947
Indexing hint: Randomized controlled trial · 2020
DeSouza et al. 2020The Journal of clinical endocrinology and metabolismcited by 43
PMID 31769496DOI 10.1210/clinem/dgz072PUB-31769496
Indexing hint: Randomized controlled trial · 2020
Jódar et al. 2020Diabetes, obesity & metabolismcited by 29
PMID 32227613PMC7383680DOI 10.1111/dom.14039PUB-32227613
Indexing hint: Randomized controlled trial · 2020
Leiter et al. 2020Diabetes, obesity & metabolismcited by 29
PMID 32372454PMC7496251DOI 10.1111/dom.14079PUB-32372454
Indexing hint: Randomized controlled trial · 2020
Verma et al. 2020Diabetes, obesity & metabolismcited by 18
PMID 32643857PMC7689837DOI 10.1111/dom.14140PUB-32643857
Indexing hint: Randomized controlled trial · 2018
Vilsbøll et al. 2018Diabetes, obesity & metabolismcited by 224
PMID 29178519PMC5888154DOI 10.1111/dom.13172PUB-29178519
Indexing hint: Randomized controlled trial · 2016
Marso et al. 2016The New England journal of medicinecited by 5,002
PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186
12 studies on this page
PubMed tag: none · 2025
Bain et al. 2025Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 8
PMID 39520501PMC11759736DOI 10.1007/s13300-024-01659-7PUB-39520501
PubMed tag: none · 2023
Rossing et al. 2023Cardiovascular diabetologycited by 17
PMID 37620807PMC10463803DOI 10.1186/s12933-023-01949-7PUB-37620807
PubMed tag: none · 2022
Verma et al. 2022Diabetes, obesity & metabolismcited by 45
PMID 35332654PMC9325529DOI 10.1111/dom.14700PUB-35332654
PubMed tag: none · 2021
Verma et al. 2021Diabetes, obesity & metabolismcited by 5
PMID 33606902PMC8251906DOI 10.1111/dom.14360PUB-33606902
PubMed tag: none · 2020
Husain et al. 2020Diabetes, obesity & metabolismcited by 154
PMID 31903692PMC7064975DOI 10.1111/dom.13955PUB-31903692
PubMed tag: none · 2020
Verma et al. 2020Diabetes, obesity & metabolismcited by 74
PMID 32744418PMC7754406DOI 10.1111/dom.14160PUB-32744418
PubMed tag: none · 2020
Husain et al. 2020Cardiovascular diabetologycited by 33
PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732
Indexing hint: Review · 2019
Aroda et al. 2019Diabetes & metabolismcited by 227
PMID 30615985DOI 10.1016/j.diabet.2018.12.001PUB-30615985
PubMed tag: none · 2019
Verma et al. 2019Diabetes, obesity & metabolismcited by 24
PMID 30851070PMC6619033DOI 10.1111/dom.13698PUB-30851070
PubMed tag: none · 2019
Leiter et al. 2019Cardiovascular diabetologycited by 87
PMID 31167654PMC6551895DOI 10.1186/s12933-019-0871-8PUB-31167654
PubMed tag: none · 2018
Wittbrodt et al. 2018The American journal of managed carecited by 21
PMID 29693361PUB-29693361
PubMed tag: none · 2018
Carlsson Petri et al. 2018Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 43
PMID 29907893PMC6064581DOI 10.1007/s13300-018-0458-5PUB-29907893
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