Phase 3 · Dulaglutide

SUSTAIN 7 trial results

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

Change in HbA1c (percentage of HbA1c), Week 0, week 40. Semaglutide 0.5 mg: -1.51; Semaglutide 1.0 mg: -1.78; Dulaglutide 0.75 mg: -1.11; Dulaglutide 1.5 mg: -1.37.

Participants
1,201
Status
completed
Completed
2017-05-19
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02648204), updated at source Oct 15, 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 7 measured first

Change in HbA1cpercentage of HbA1c · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=301Semaglutide 1.0 mgn=300Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=299
-1.51(0.06)-1.78(0.06)-1.11(0.05)-1.37(0.06)
Side effects by arm

Side effects in SUSTAIN 7

Percent of participants affected, Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days). The most common events the registry lists.

EventSemaglutide 0.5 mgSemaglutide 1.0 mgDulaglutide 0.75 mgDulaglutide 1.5 mg
Any serious event5.6%7.7%8%7.4%
Nausea22.3%21%13%20.1%
Diarrhoea14.3%13.7%7.7%17.7%
Decreased appetite8.3%9%3%10.4%
Vomiting10%10.3%4%9.7%
Headache8.3%7.3%4%6.4%
Upper respiratory tract infection4.3%3.3%7%5.4%
Nasopharyngitis5%4.7%5.7%6.7%
Lipase increased6.3%5.7%5.4%5.7%
Constipation5.3%4.7%3.3%5%
Secondary outcomes

What else it measured

Change in Body Weight (kg)kg · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=301Semaglutide 1.0 mgn=300Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=298
-4.56(0.28)-6.53(0.28)-2.30(0.27)-2.98(0.27)
Change in Fasting Plasma Glucosemmol/L · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=298Semaglutide 1.0 mgn=299Dulaglutide 0.75 mgn=297Dulaglutide 1.5 mgn=297
-2.18(0.12)-2.83(0.12)-1.87(0.12)-2.25(0.12)
Change in Systolic and Diastolic Blood PressuremmHg · Week 0, week 40 · least squares mean
MeasureSemaglutide 0.5 mgn=301Semaglutide 1.0 mgn=300Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=299
Diastolic BP-0.57(0.48)-2.05(0.49)-0.35(0.47)-0.03(0.47)
Systolic BP-2.44(0.76)-4.88(0.77)-2.16(0.75)-2.86(0.75)
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaireunits on a scale · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=301Semaglutide 1.0 mgn=299Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=298
4.60(0.28)4.55(0.29)4.52(0.28)4.65(0.28)
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Targetpercentage of subjects · After 40 weeks treatment · number
MeasureSemaglutide 0.5 mgn=301Semaglutide 1.0 mgn=300Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=299
Yes49.266.734.147.2
No50.833.365.952.8
Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profilemmol/L · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=295Semaglutide 1.0 mgn=295Dulaglutide 0.75 mgn=296Dulaglutide 1.5 mgn=296
-2.43(0.10)-2.95(0.10)-1.99(0.10)-2.32(0.10)
Change From Baseline 7-point Self-measured Plasma Glucose Incrementmmol/L · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=295Semaglutide 1.0 mgn=292Dulaglutide 0.75 mgn=296Dulaglutide 1.5 mgn=296
-0.77(0.08)-0.93(0.09)-0.44(0.08)-0.63(0.08)
Change in Fasting Blood Lipids (Total Cholesterol)ratio to baseline · Week 0, week 40 · geometric least squares mean
Semaglutide 0.5 mgn=295Semaglutide 1.0 mgn=296Dulaglutide 0.75 mgn=290Dulaglutide 1.5 mgn=294
0.96(0.01)0.97(0.01)0.97(0.01)0.99(0.01)
Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)ratio to baseline · Week 0, week 40 · geometric least squares mean
Semaglutide 0.5 mgn=293Semaglutide 1.0 mgn=295Dulaglutide 0.75 mgn=290Dulaglutide 1.5 mgn=294
0.97(0.02)1.00(0.02)0.97(0.02)1.01(0.02)
Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)ratio to baseline · Week 0, week 40 · geometric least squares mean
Semaglutide 0.5 mgn=293Semaglutide 1.0 mgn=296Dulaglutide 0.75 mgn=290Dulaglutide 1.5 mgn=294
0.99(0.01)1.01(0.01)1.00(0.01)1.02(0.01)
Change in Fasting Blood Lipids (Triglycerides)ratio to baseline · Week 0, week 40 · geometric least squares mean
Semaglutide 0.5 mgn=293Semaglutide 1.0 mgn=296Dulaglutide 0.75 mgn=290Dulaglutide 1.5 mgn=294
0.91(0.02)0.86(0.02)0.91(0.02)0.90(0.02)
Change in Body Mass Index (BMI)kg/m^2 · Week 0, week 40 · least squares mean
Semaglutide 0.5 mgn=301Semaglutide 1.0 mgn=300Dulaglutide 0.75 mgn=299Dulaglutide 1.5 mgn=298
-1.63(0.10)-2.33(0.10)-0.82(0.10)-1.08(0.10)
The trial

How SUSTAIN 7 was run

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

  • Semaglutide 0.5 mg/Week
  • Semaglutide 1.0 mg/Week
  • Dulaglutide 0.75 mg/Week
  • Dulaglutide 1.5 mg/Week
Who could join the trial

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening 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 (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Published papers

Papers from SUSTAIN 7

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

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