Phase 3 · Semaglutide

SUSTAIN1 trial results

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Change in HbA1c (Glycosylated Haemoglobin) (Percentage of HbA1c), Week 0, week 30. Semaglutide 0.5 mg: -1.47; Semaglutide 1.0 mg: -1.56; Placebo: -0.00.

Participants
388
Status
completed
Completed
2015-05-08
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02054897), updated at source Jun 12, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SUSTAIN1 measured first

Change in HbA1c (Glycosylated Haemoglobin)Percentage of HbA1c · Week 0, week 30 · mean
Semaglutide 0.5 mgn=128Semaglutide 1.0 mgn=130Placebon=129
-1.47(1.02)-1.56(1.26)-0.00(0.90)
Side effects by arm

Side effects in SUSTAIN1

Percent of participants affected, From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product.... The most common events the registry lists.

EventSemaglutide 0.5 mgSemaglutide 1.0 mgPlacebo
Any serious event5.5%5.4%3.9%
Nausea20.3%23.8%7.8%
Diarrhoea12.5%10.8%2.3%
Headache11.7%6.9%6.2%
Vomiting3.9%6.9%1.6%
Constipation6.3%3.8%0.8%
Lipase increased6.3%3.8%3.9%
Dyspepsia5.5%3.8%2.3%
Nasopharyngitis4.7%4.6%5.4%
Secondary outcomes

What else it measured

Change in Body Weightkilogram(s) · Week 0, week 30 · mean
Semaglutide 0.5 mgn=128Semaglutide 1.0 mgn=130Placebon=129
-3.68(4.03)-4.67(5.19)-0.89(3.46)
Change in Fasting Plasma Glucose (FPG)mmol/L · Week 0, week 30 · mean
Semaglutide 0.5 mgn=125Semaglutide 1.0 mgn=129Placebon=127
-2.41(2.55)-2.39(2.74)-0.55(2.2)
Change in Systolic and Diastolic Blood PressuremmHg · Week 0, week 30 · mean
MeasureSemaglutide 0.5 mgn=128Semaglutide 1.0 mgn=130Placebon=129
Systolic blood pressure-2.29(12.58)-2.74(11.58)-2.01(11.23)
Diastolic blood pressure-0.73(6.88)0.22(7.6)0.60(7.59)
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association TargetPercentage of subjects · At 30 weeks of treatment · number
MeasureSemaglutide 0.5 mgn=128Semaglutide 1.0 mgn=130Placebon=129
Yes74.272.324.8
No25.827.775.2
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists TargetPercentage of subjects · At 30 weeks of treatment · number
MeasureSemaglutide 0.5 mgn=128Semaglutide 1.0 mgn=130Placebon=129
Yes59.460.013.2
No40.640.086.8
The trial

How SUSTAIN1 was run

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

  • Semaglutide 1.0 mg
  • Semaglutide 0.5 mg
  • Semaglutide placebo 1.0 mg
  • Semaglutide placebo 0.5 mg
Who could join the trial

Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - 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 is of child-bearing potential and 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. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - 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 any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness - 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 or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) 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 - Heart failure, New York Heart Association class IV

Published papers

Papers from SUSTAIN1

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.