Primary outcomeLeast squares mean· Week 0, week 56
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -1.54 | 0.06 |
| Exenatide ER 2.0 mg | -0.92 | 0.06 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Short name SUSTAIN™ 3
NCTNCT01885208 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3624Other id2012-004826-92Other idU1111-1135-8647
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 813 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
13 countries
United States, Argentina, Croatia, Finland, France, Germany, Greece, Italy, Netherlands, Puerto Rico, Serbia, Switzerland, United Kingdom
- Start
- 2 Dec 2013
- Primary completion
- 13 Jul 2015
- Completion
- 13 Jul 2015
- First posted
- 24 Jun 2013 (estimated)
- Last update posted
- 13 Jun 2019
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2013201420152016
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
Interventions
- semaglutideDrug
- exenatideDrug
Arms2
Experimental
Semaglutide 1.0 mg
Active comparator
Exenatide ER 2.0 mg
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 56
Registry description
Mean change in HbA1c from baseline to week 56.
Secondary outcomes(5)
Change From Baseline in Body Weight
Time frame · Week 0, week 56
Registry description
Mean change in body weight from baseline to week 56.
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 56
Registry description
Mean change in FPG from baseline to week 56.
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame · Week 0, week 56
Registry description
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
Time frame · Week 0, week 56
Registry description
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
Time frame · After 56 weeks' treatment
Registry description
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Week 0, week 56
Change From Baseline in Body Weight
| Group | Value (kilograms) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -5.63 | 0.29 |
| Exenatide ER 2.0 mg | -1.85 | 0.29 |
Secondary outcomeLeast squares mean· Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -51.22 | 2.36 |
| Exenatide ER 2.0 mg | -36.1 | 2.45 |
Secondary outcomeLeast squares mean· Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
| Group | Value (mm Hg) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -4.6 | 0.68 |
| Exenatide ER 2.0 mg | -2.23 | 0.7 |
Secondary outcomeLeast squares mean· Week 0, week 56
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
| Group | Value (Units on a scale) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | 4.98 | 0.26 |
| Exenatide ER 2.0 mg | 3.96 | 0.27 |
Secondary outcomeCount of participants· After 56 weeks' treatment
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
| Group | Value (Participants) |
|---|---|
| Semaglutide 1.0 mg | 190 |
| Exenatide ER 2.0 mg | 89 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Sema 1.0 mgSubjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD)therapy throughout the trial, unless rescue medication was needed. | – | 38 / 404 | 194 / 404 |
| Exenatide ERSubjects randomised to exenatide extended release (ER) 2.0 mg(Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed. | – | 24 / 405 | 187 / 405 |
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
Studies18
Studies that cite this trial.
Studies with results
8 studies on this page
Indexing hint: Randomized controlled trial · 2020
9 results
Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.
DeSouza et al. 2020The Journal of clinical endocrinology and metabolismcited by 43
PMID 31769496DOI 10.1210/clinem/dgz072PUB-31769496
Rights unknown9 results
Indexing hint: Meta-analysis (pooled) · 2020
4 results
Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.
Lingvay et al. 2020The Journal of clinical endocrinology and metabolismcited by 19
PMID 32827435PMC7549924DOI 10.1210/clinem/dgaa577PUB-32827435
CC BY4 results
Indexing hint: Randomized controlled trial · 2019
6 results
Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach.
Overgaard et al. 2019Diabetes, obesity & metabolismcited by 26
PMID 30047216PMC6585654DOI 10.1111/dom.13479PUB-30047216
Free to read · publisher termsCC BY-NC6 results
PubMed tag: none · 2019
8 results
GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.
Rodbard et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 17
PMID 30865526DOI 10.4158/ep-2018-0444PUB-30865526
Full text at the publisher8 results
Indexing hint: Randomized controlled trial · 2019
6 results
Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.
Jendle et al. 2019Diabetes, obesity & metabolismcited by 17
PMID 31215727PMC6771774DOI 10.1111/dom.13816PUB-31215727
Free to read · publisher termsCC BY-NC6 results
Indexing hint: Randomized controlled trial · 2018
11 results
Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
Ahmann et al. 2018Diabetes carecited by 481
PMID 29246950DOI 10.2337/dc17-0417PUB-29246950
Full text at the publisher11 results
Indexing hint: Randomized controlled trial · 2018
6 results
Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
Warren et al. 2018Diabetes, obesity & metabolismcited by 54
PMID 29687620PMC6099273DOI 10.1111/dom.13331PUB-29687620
Free to read · publisher termsCC BY-NC6 results
Indexing hint: Randomized controlled trial · 2018
5 results
Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.
Ahrén et al. 2018Diabetes, obesity & metabolismcited by 122
PMID 29766634PMC6099440DOI 10.1111/dom.13353PUB-29766634
Free to read · publisher termsCC BY-NC5 results
More studies
10 studies on this page
PubMed tag: none · 2022
Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials.
Mosenzon et al. 2022Cardiovascular diabetologycited by 65
PMID 36056351PMC9440529DOI 10.1186/s12933-022-01585-7PUB-36056351
CC BY
PubMed tag: none · 2020
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain et al. 2020Diabetes, obesity & metabolismcited by 154
PMID 31903692PMC7064975DOI 10.1111/dom.13955PUB-31903692
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2020
Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10.
Capehorn et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10
PMID 32193837PMC7193006DOI 10.1007/s13300-020-00796-zPUB-32193837
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2020
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain et al. 2020Cardiovascular diabetologycited by 33
PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732
CC BY
PubMed tag: none · 2019
Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia.
Malkin et al. 2019Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 16
PMID 30535837PMC6349296DOI 10.1007/s13300-018-0542-xPUB-30535837
Free to read · publisher termsCC BY-NC
Indexing hint: Review · 2019
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.
Aroda et al. 2019Diabetes & metabolismcited by 227
PMID 30615985DOI 10.1016/j.diabet.2018.12.001PUB-30615985
Full text at the publisher
PubMed tag: none · 2019
Corrected
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.
Fonseca et al. 2019The Journal of clinical endocrinology and metabolismcited by 49
PMID 30938762DOI 10.1210/jc.2018-02685PUB-30938762
Rights unknown
PubMed tag: none · 2018
Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.
Petri et al. 2018Diabetes, obesity & metabolismcited by 47
PMID 29748996PMC6099226DOI 10.1111/dom.13358PUB-29748996
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2018
Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.
DeVries et al. 2018Diabetes, obesity & metabolismcited by 19
PMID 29862621PMC6175309DOI 10.1111/dom.13396PUB-29862621
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2018
Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
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
Free to read · publisher termsCC BY-NC
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
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