LivingGLP1
Study S001219

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Registration

Registration
NCT02128932
Acronym
SUSTAIN™ 4
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
1089
Start
2014-08-04
Primary completion
2015-09-03
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:semaglutide; DRUG:insulin glargine
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2013-004392-12; OTHER:U1111-1146-0211; REGISTRY:NL47781.018.14

Registered primary outcomes

  • Change in HbA1c From Baseline [Week 0, week 30]

Linked records (12)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0012216Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10.
Capehorn M, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Randomized trialPMID 32193837DOIcites ClinicalTrials.gov:NCT02128932; registry reference DERIVED:32193837
R0015927Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.
DeSouza C, The Journal of clinical endocrinology and metabolism
2020Randomized trialPMID 31769496DOIcites ClinicalTrials.gov:NCT02128932; registry reference DERIVED:31769496
R0018529Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain M, Cardiovascular diabetology
2020Randomized trialPMID 32998732DOIcites ClinicalTrials.gov:NCT02128932; registry reference DERIVED:32998732
R0018857Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain M, Diabetes, obesity & metabolism
2020OtherPMID 31903692DOIcites ClinicalTrials.gov:NCT02128932; registry reference DERIVED:31903692
R0009827GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.
Rodbard HW, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2019Other trialPMID 30865526DOIregistry reference BACKGROUND:30865526
R0012485Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.
Jendle J, Diabetes, obesity & metabolism
2019Other trialPMID 31215727DOIcites ClinicalTrials.gov:NCT02128932; cites EudraCT:2013-004392-12; registry reference DERIVED:31215727
R0013158Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials.
Aroda VR, Diabetes & metabolism
2019Other trialPMID 30615985DOIregistry reference RESULT:30615985
R0018825Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.
Ahrén B, Diabetes, obesity & metabolism
2018Randomized trialPMID 29766634DOIregistry reference RESULT:29766634
R0022511Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
Warren M, Diabetes, obesity & metabolism
2018Randomized trialPMID 29687620DOIregistry reference RESULT:29687620
R0023345Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.
DeVries JH, Diabetes, obesity & metabolism
2018Randomized trialPMID 29862621DOIregistry reference RESULT:29862621
R0021892Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.
Kapitza C, Diabetologia
2017Randomized trialPMID 28526920DOIregistry reference RESULT:28526920
R0022177Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial.
Aroda VR, The lancet. Diabetes & endocrinology
2017Randomized trialPMID 28344112DOIcites ClinicalTrials.gov:NCT02128932; registry reference RESULT:28344112