Phase 3 · Semaglutide

SUSTAIN 5 trial results

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

Change in HbA1c (Glycosylated Haemoglobin) (percentage of glycosylated hemoglobin), Week 0, week 30. Semaglutide 0.5 mg: -1.45; Semaglutide 1.0 mg: -1.85; Placebo: -0.09.

Participants
397
Status
completed
Completed
2015-11-21
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02305381), updated at source Jun 11, 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 5 measured first

Change in HbA1c (Glycosylated Haemoglobin)percentage of glycosylated hemoglobin · Week 0, week 30 · least squares mean
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
-1.45(0.09)-1.85(0.09)-0.09(0.09)
Side effects by arm

Side effects in SUSTAIN 5

Percent of participants affected, From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a.... The most common events the registry lists.

EventSemaglutide 0.5 mgSemaglutide 1.0 mgPlacebo
Any serious event6.1%9.2%6.8%
Nausea11.4%16.8%4.5%
Vomiting6.1%11.5%3%
Nasopharyngitis8.3%4.6%10.5%
Lipase increased9.1%5.3%3%
Diarrhoea4.5%6.9%1.5%
Upper respiratory tract infection6.1%0.8%3%
Urinary tract infection1.5%3.1%6%
Decreased appetite3.8%5.3%0.8%
Secondary outcomes

What else it measured

Change in Body Weightkg · Week 0, week 30 · least squares mean
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
-3.67(0.36)-6.42(0.36)-1.36(0.37)
Change in Fasting Plasma Glucose (FPG)mg/dL · week 0, week 30 · least squares mean
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
-29.14(3.74)-42.38(3.76)-8.51(4.02)
Change in Insulin Doseratio · week 0, week 30 · least squares mean
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
0.90(0.01)0.85(0.01)0.96(0.01)
Change in Systolic and Diastolic Blood Pressuremm Hg · week 0, week 30 · least squares mean
MeasureSemaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
Diastolic blood pressure-1.84(0.73)-1.50(0.74)-2.17(0.79)
Systolic blood pressure-4.29(1.26)-7.27(1.27)-0.99(1.34)
Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)scores on a scale · week 0, week 30 · least squares mean
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
2.73(0.46)3.47(0.46)1.25(0.50)
HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Targetpercentage of subjects · After 30 weeks treatment · number
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
60.678.610.5
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Targetpercentage of subjects · After 30 weeks treatment · number
Semaglutide 0.5 mgn=132Semaglutide 1.0 mgn=131Placebon=133
40.961.14.5
The trial

How SUSTAIN 5 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 once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

  • Semaglutide 0.5 mg/Week
  • Semaglutide 1.0 mg/Week
  • Semaglutide Placebo 0.5 mg/Week
  • Semaglutide Placebo 1.0 mg/Week
Who could join the trial

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (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 an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - History of pancreatitis (acute or chronic) - 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 2 (MEN 2) - Severe renal impairment 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 (NYHA) Class IV

Published papers

Papers from SUSTAIN 5

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.