Phase 3 · Semaglutide

SUSTAIN trial results

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Number of Treatment Emergent Adverse Events (TEAEs) (Number of events), Weeks 0-30. Semaglutide 0.5 mg: 228; Semaglutide 1.0 mg: 197; Sitagliptin: 186.

Participants
308
Status
completed
Completed
2015-11-11
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02254291), updated at source Sep 13, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SUSTAIN measured first

Number of Treatment Emergent Adverse Events (TEAEs)Number of events · Weeks 0-30 · number
Semaglutide 0.5 mgn=103Semaglutide 1.0 mgn=102Sitagliptinn=103
228197186
Side effects by arm

Side effects in SUSTAIN

Percent of participants affected, All AEs 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 randomised.... The most common events the registry lists.

EventSemaglutide 0.5 mgSemaglutide 1.0 mgSitagliptin
Any serious event5.8%2%1.9%
Nasopharyngitis16.5%17.6%29.1%
Constipation14.6%11.8%3.9%
Nausea10.7%12.7%0%
Lipase increased9.7%6.9%3.9%
Diarrhoea6.8%8.8%1.9%
Decreased appetite8.7%7.8%0%
Abdominal discomfort3.9%6.9%0%
Amylase increased5.8%2%1.9%
Secondary outcomes

What else it measured

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesNumber of episodes · Weeks 0-30 · number
Semaglutide 0.5 mgn=103Semaglutide 1.0 mgn=102Sitagliptinn=103
010
Change in Glycosylated Haemoglobin A1c (HbA1c)Percentage of glycosylated haemoglobin · Week 0 and week 30 · least squares mean
Semaglutide 0.5 mgn=103Semaglutide 1.0 mgn=102Sitagliptinn=103
-1.87(0.07)-2.18(0.07)-0.74(0.07)
The trial

How SUSTAIN was run

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

  • Semaglutide 0.5 mg
  • Semaglutide 1.0 mg
  • Sitagliptin 100 mg
Who could join the trial

Inclusion Criteria: * Male or female, age 20 years or older at the time of signing informed consent * Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening * Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2) Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period * Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening * Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness * Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * History of chronic or idiopathic acute pancreatitis * Screening calcitonin value of 50 ng/L (pg/mL) or greater * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Impaired renal function defined as estimated glomerular filtration rate (eGFR) less than 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

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

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