Phase 3 · Semaglutide

SUSTAIN 2 trial results

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)

Change in HbA1c (Glycosylated Haemoglobin) From Baseline (percentage of glycosylated haemoglobin), Week 0, week 56. Semaglutide 0.5 mg + Sitagliptin Placebo: -1.32; Semaglutide 1.0 mg + Sitagliptin Placebo: -1.61; Sitagliptin + Semaglutide Placebo: -0.55.

Participants
1,231
Status
completed
Completed
2015-10-12
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01930188), 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 2 measured first

Change in HbA1c (Glycosylated Haemoglobin) From Baselinepercentage of glycosylated haemoglobin · Week 0, week 56 · least squares mean
Semaglutide 0.5 mg + Sitagliptin Placebon=409Semaglutide 1.0 mg + Sitagliptin Placebon=409Sitagliptin + Semaglutide Placebon=407
-1.32(0.05)-1.61(0.05)-0.55(0.05)
Side effects by arm

Side effects in SUSTAIN 2

Percent of participants affected, Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks).. The most common events the registry lists.

EventSemaglutide 1.0 mg + Sitagliptin PlaceboSemaglutide 0.5 mg + Sitagliptin PlaceboSitagliptin 100 mg + Semaglutide Placebo 1.0 mgSitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Any serious event7.3%7.3%6.4%7.9%
Nausea17.6%17.8%6.4%8.4%
Diarrhoea13%13%6.4%7.9%
Nasopharyngitis7.1%12.2%9.3%11.3%
Vomiting10%8.1%2.9%2.5%
Lipase increased7.8%8.1%6.4%7.9%
Headache7.1%6.4%4.4%3.9%
Influenza5.4%4.4%6.4%6.9%
Decreased appetite6.6%6.4%2.9%2.5%
Dyspepsia4.9%6.4%2%2.5%
Pharyngitis2.4%1.7%2.5%6.4%
Constipation5.6%4.4%2.5%1.5%
Secondary outcomes

What else it measured

Change in Body Weight From Baselinekilograms · Week 0, week 56 · least squares mean
Semaglutide 0.5 mg + Sitagliptin Placebon=409Semaglutide 1.0 mg + Sitagliptin Placebon=409Sitagliptin + Semaglutide Placebon=407
-4.28(0.25)-6.13(0.25)-1.93(0.26)
Change in Fasting Plasma Glucose (FPG) From Baselinemg/dL · Week 0, week 56 · least squares mean
Semaglutide 0.5 mg + Sitagliptin Placebon=409Semaglutide 1.0 mg + Sitagliptin Placebon=409Sitagliptin + Semaglutide Placebon=407
-37.38(1.79)-46.72(1.78)-19.85(1.88)
Change in Systolic and Diastolic Blood Pressure From BaselinemmHg · Week 0, week 56 · least squares mean
MeasureSemaglutide 0.5 mg + Sitagliptin Placebon=409Semaglutide 1.0 mg + Sitagliptin Placebon=409Sitagliptin + Semaglutide Placebon=407
Systolic blood pressure-5.07(0.64)-5.61(0.63)-2.29(0.67)
Diastolic blood pressure-2.01(0.42)-1.91(0.42)-1.11(0.44)
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From BaselineUnits on a scale · Week 0, week 56 · least squares mean
Semaglutide 0.5 mg + Sitagliptin Placebon=333Semaglutide 1.0 mg + Sitagliptin Placebon=333Sitagliptin + Semaglutide Placebon=294
5.28(0.23)5.91(0.23)4.45(0.24)
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)Subjects · After 56 weeks treatment · number
MeasureSemaglutide 0.5 mg + Sitagliptin Placebon=409Semaglutide 1.0 mg + Sitagliptin Placebon=409Sitagliptin + Semaglutide Placebon=407
Yes21527083
No194139324
The trial

How SUSTAIN 2 was run

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.

  • Semaglutide 0.5 mg + sitagliptin placebo
  • Semaglutide 1.0 mg + sitagliptin placebo
  • Sitagliptin 100 mg + semaglutide placebo 1.0 mg
  • Sitagliptin 100 mg + semaglutide placebo 0.5 mg
Who could join the trial

Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). 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 weeks 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 (below or equal to 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 (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 m2 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 2

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

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