Phase 3 · Semaglutide

SUSTAIN 4 trial results

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Change in HbA1c From Baseline (percentage), Week 0, week 30. Semaglutide 0.5mg/Week: -1.21; Semaglutide 1.0 mg/Week: -1.64; Insulin Glargine: -0.83.

Participants
1,089
Status
completed
Completed
2015-09-03
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02128932), 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 4 measured first

Change in HbA1c From Baselinepercentage · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
-1.21(0.05)-1.64(0.05)-0.83(0.05)
Side effects by arm

Side effects in SUSTAIN 4

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

EventSemaglutide 0.5mg/WeekSemaglutide 1.0 mg/WeekInsulin Glargine
Any serious event6.1%4.7%5%
Nausea21.3%22.2%3.3%
Diarrhoea16.3%19.2%4.4%
Nasopharyngitis12.4%8.1%12.2%
Vomiting6.6%10.3%2.8%
Lipase increased9.9%8.3%4.2%
Decreased appetite6.9%6.4%0.3%
Dyspepsia3.3%6.7%0.6%
Upper respiratory tract infection2.8%3.9%6.7%
Headache5.2%6.4%5.6%
Gastrooesophageal reflux disease1.1%5.3%0.8%
Back pain3%5%1.9%
Secondary outcomes

What else it measured

Change in Body Weight From BaselineKg · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
-3.47(0.24)-5.17(0.24)1.15(0.23)
Change in Fasting Plasma Glucose From Baselinemg/dL · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
-36.74(2.14)-49.21(2.15)-38.18(2.03)
Change in Diastolic Blood Pressure.mmHg · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
-1.38(0.43)-0.98(0.44)-1.44(0.41)
Change in Systolic Blood Pressure.mmHg · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
-4.65(0.72)-5.17(0.73)-1.68(0.68)
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™T-scores · Week 0, week 30 · least squares mean
MeasureSemaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
Bodily pain0.95(0.51)1.76(0.51)0.90(0.48)
General Health1.95(0.38)2.78(0.38)1.63(0.36)
Mental Component summary, MCS1.23(0.47)1.33(0.47)0.25(0.44)
Mental Health1.69(0.46)1.17(0.47)0.54(0.44)
Physical Component summary, PCS1.18(0.36)2.09(0.36)1.18(0.34)
Physical Functioning1.64(0.43)1.49(0.43)0.69(0.41)
Role-emotional0.88(0.54)1.73(0.54)0.06(0.51)
Role-physical0.90(0.46)1.97(0.46)0.78(0.43)
Social functioning1.13(0.48)1.04(0.48)0.36(0.45)
Vitality1.71(0.46)2.09(0.46)0.95(0.44)
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)Score on a scale · Week 0, week 30 · least squares mean
Semaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
4.86(0.28)5.37(0.29)3.99(0.27)
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)Count of participants · After 30 weeks treatment · number
MeasureSemaglutide 0.5mg/Weekn=362Semaglutide 1.0 mg/Weekn=360Insulin Glarginen=360
Yes13519563
No227165297
The trial

How SUSTAIN 4 was run

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

  • Semaglutide 0.5 mg/week
  • Semaglutide 1.0 mg/week
  • Insulin glargine
Who could join the trial

Inclusion Criteria: * Male or female, 18 years or older at the time of signing informed consent * Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose * HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period * Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol * Treatment with any 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 intercurrent illness * History of chronic or idiopathic acute pancreatitis * Screening calcitonin value greater than or equal to 50 ng/L * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2 * Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 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 Class IV * Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator * Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Published papers

Papers from SUSTAIN 4

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.