Phase 3 · Semaglutide

SUSTAIN 3 trial results

Efficacy 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 (SUSTAIN™ 3 - vs. QW GLP-1)

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (percentage of glycosylated haemoglobin), Week 0, week 56. Semaglutide 1.0 mg: -1.54; Exenatide ER 2.0 mg: -0.92.

Participants
813
Status
completed
Completed
2015-07-13
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01885208), updated at source Jun 13, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SUSTAIN 3 measured first

Change From Baseline in HbA1c (Glycosylated Haemoglobin)percentage of glycosylated haemoglobin · Week 0, week 56 · least squares mean
Semaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
-1.54(0.06)-0.92(0.06)
Side effects by arm

Side effects in SUSTAIN 3

Percent of participants affected, All adverse events are treatment-emergent adverse events (TEAEs). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised.... The most common events the registry lists.

EventSema 1.0 mgExenatide ER
Any serious event9.4%5.9%
Nausea22.3%11.9%
Injection site nodule0%12.1%
Lipase increased10.1%12.1%
Diarrhoea11.4%8.4%
Nasopharyngitis9.7%9.4%
Headache9.4%9.6%
Decreased appetite7.9%5.2%
Vomiting7.2%6.2%
Dyspepsia6.7%4.7%
Constipation6.4%5.2%
Secondary outcomes

What else it measured

Change From Baseline in Body Weightkilograms · Week 0, week 56 · least squares mean
Semaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
-5.63(0.29)-1.85(0.29)
Change From Baseline in Fasting Plasma Glucose (FPG)mg/dL · Week 0, week 56 · least squares mean
Semaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
-51.22(2.36)-36.1(2.45)
Change From Baseline in Systolic and Diastolic Blood Pressuremm Hg · Week 0, week 56 · least squares mean
MeasureSemaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
Systolic blood pressure-4.6(0.68)-2.23(0.7)
Diastolic blood pressure-1.0(0.45)-0.1(0.46)
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)Units on a scale · Week 0, week 56 · least squares mean
Semaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
4.98(0.26)3.96(0.27)
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)Participants · After 56 weeks' treatment · count of participants
MeasureSemaglutide 1.0 mgn=404Exenatide ER 2.0 mgn=405
Yes19089
No214316
The trial

How SUSTAIN 3 was run

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.

  • Semaglutide 1.0 mg
  • Exenatide ER 2.0 mg
Who could join the trial

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

Published papers

Papers from SUSTAIN 3

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.