Phase 3 · Semaglutide

SUSTAIN trial results

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

Number of Treatment Emergent Adverse Events (TEAEs) (Number of events), Weeks 0-56. Semaglutide 0.5 mg: 909; Semaglutide 1.0 mg: 954; Additional OAD: 269.

Participants: 601
Status: completed
Completed: 2016-02-27
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02207374), updated at source Jan 7, 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 measured first

Number of Treatment Emergent Adverse Events (TEAEs)Number of events · Weeks 0-56 · number

Semaglutide 0.5 mgn=239	Semaglutide 1.0 mgn=241	Additional OADn=120
909	954	269

Side effects by arm

Side effects in SUSTAIN

Percent of participants affected, All AEs mentioned here are treatment emergent adverse events (TEAE), defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment.... The most common events the registry lists.

Event	Semaglutide 0.5 mg	Semaglutide 1.0 mg	Additional OAD
Any serious event	7.9%	5%	6.7%
Nasopharyngitis	33.9%	31.1%	34.2%
Nausea	12.1%	19.1%	0.8%
Constipation	18.4%	14.9%	4.2%
Diarrhoea	10%	15.8%	6.7%
Lipase increased	8.8%	13.7%	1.7%
Decreased appetite	7.5%	13.3%	0%
Back pain	3.8%	5.4%	8.3%
Diabetic retinopathy	4.6%	6.6%	5%
Abdominal discomfort	6.3%	6.2%	0%
Gastroenteritis	6.3%	2.1%	1.7%
Vomiting	5.4%	5.8%	1.7%
Amylase increased	2.9%	5.4%	0.8%
Pharyngitis	5%	3.7%	1.7%

Secondary outcomes

What else it measured

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesNumber of episodes · Weeks 0-56 · number

Semaglutide 0.5 mgn=239	Semaglutide 1.0 mgn=241	Additional OADn=120
4	8	2

Change in Glycosylated Haemoglobin A1c (HbA1c)Percentage (%) of HbA1c · Week 0, week 56 · least squares mean

Semaglutide 0.5 mgn=220	Semaglutide 1.0 mgn=204	Additional OADn=106
-1.74(0.05)	-2.03(0.05)	-0.67(0.07)

The trial

How SUSTAIN was run

This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy. All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Semaglutide 0.5 mg
Semaglutide 1.0 mg
One additional OAD + pre-trial treatment: The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different...

Who could join the trial

Inclusion Criteria: * Male or female, age at least 20 years at the time of signing informed consent * HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) * Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (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 \[not having sex\], diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period * Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days 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 above or equal to 50 ng/L (pg/mL) * 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) below 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 (Visit 2 \[week 0\]) * 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.

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.