Primary outcomeMean· Week 0, week 30
Change in HbA1c (Glycosylated Haemoglobin)
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.47 | 1.02 |
| Semaglutide 1.0 mg | -1.56 | 1.26 |
| Placebo | -0.00 | 0.90 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Short name SUSTAIN™1
NCTNCT02054897 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3623Other id2013-000632-94Other idU1111-1139-3090Other idJapicCTI-142442
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 388 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
9 countries
United States, Canada, Italy, Japan, Mexico, Romania, Russia, South Africa, United Kingdom
- Start
- 3 Feb 2014
- Primary completion
- 8 May 2015
- Completion
- 8 May 2015
- First posted
- 4 Feb 2014 (estimated)
- Last update posted
- 12 Jun 2019
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- semaglutideDrug
- placeboDrug
Arms4
Experimental
Semaglutide 1.0 mg
Experimental
Semaglutide 0.5 mg
Placebo comparator
Semaglutide placebo 1.0 mg
Placebo comparator
Semaglutide placebo 0.5 mg
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 30
Registry description
Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Secondary outcomes(5)
Change in Body Weight
Time frame · Week 0, week 30
Registry description
Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change in Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 30
Registry description
Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change in Systolic and Diastolic Blood Pressure
Time frame · Week 0, week 30
Registry description
Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
Time frame · At 30 weeks of treatment
Registry description
Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Time frame · At 30 weeks of treatment
Registry description
Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMean· Week 0, week 30
Change in Body Weight
| Group | Value (kilogram(s)) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -3.68 | 4.03 |
| Semaglutide 1.0 mg | -4.67 | 5.19 |
| Placebo | -0.89 | 3.46 |
Secondary outcomeMean· Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -2.41 | 2.55 |
| Semaglutide 1.0 mg | -2.39 | 2.74 |
| Placebo | -0.55 | 2.2 |
Secondary outcomeMean· Week 0, week 30
Change in Systolic and Diastolic Blood Pressure
| Group | Value (mmHg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -2.29 | 12.58 |
| Semaglutide 1.0 mg | -2.74 | 11.58 |
| Placebo | -2.01 | 11.23 |
Secondary outcomeNumber· At 30 weeks of treatment
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
| Group | Value (Percentage of subjects) |
|---|---|
| Semaglutide 0.5 mg | 74.2 |
| Semaglutide 1.0 mg | 72.3 |
| Placebo | 24.8 |
Secondary outcomeNumber· At 30 weeks of treatment
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
| Group | Value (Percentage of subjects) |
|---|---|
| Semaglutide 0.5 mg | 59.4 |
| Semaglutide 1.0 mg | 60.0 |
| Placebo | 13.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5 mgSubjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period. | – | 7 / 128 | 53 / 128 |
| Semaglutide 1.0 mgSubjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period. | – | 7 / 130 | 47 / 130 |
| PlaceboSubjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. 1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. 2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period. | – | 5 / 129 | 27 / 129 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies13
Studies that cite this trial.
Studies with results
6 studies on this page
Indexing hint: Randomized controlled trial · 2020
9 results
Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.
DeSouza et al. 2020The Journal of clinical endocrinology and metabolismcited by 43
PMID 31769496DOI 10.1210/clinem/dgz072PUB-31769496
Rights unknown9 results
Indexing hint: Randomized controlled trial · 2019
6 results
Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach.
Overgaard et al. 2019Diabetes, obesity & metabolismcited by 26
PMID 30047216PMC6585654DOI 10.1111/dom.13479PUB-30047216
Free to read · publisher termsCC BY-NC6 results
PubMed tag: none · 2019
8 results
GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.
Rodbard et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 17
PMID 30865526DOI 10.4158/ep-2018-0444PUB-30865526
Full text at the publisher8 results
Indexing hint: Randomized controlled trial · 2018
6 results
Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
Warren et al. 2018Diabetes, obesity & metabolismcited by 54
PMID 29687620PMC6099273DOI 10.1111/dom.13331PUB-29687620
Free to read · publisher termsCC BY-NC6 results
Indexing hint: Randomized controlled trial · 2018
5 results
Semaglutide 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 et al. 2018Diabetes, obesity & metabolismcited by 122
PMID 29766634PMC6099440DOI 10.1111/dom.13353PUB-29766634
Free to read · publisher termsCC BY-NC5 results
Indexing hint: Randomized controlled trial · 2017
12 results
Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.
Sorli et al. 2017The lancet. Diabetes & endocrinologycited by 600
PMID 28110911DOI 10.1016/s2213-8587(17)30013-xPUB-28110911
Rights unknown12 results
More studies
7 studies on this page
PubMed tag: none · 2020
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain et al. 2020Diabetes, obesity & metabolismcited by 154
PMID 31903692PMC7064975DOI 10.1111/dom.13955PUB-31903692
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2020
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain et al. 2020Cardiovascular diabetologycited by 33
PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732
CC BY
Indexing hint: Review · 2019
Comparative 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 et al. 2019Diabetes & metabolismcited by 227
PMID 30615985DOI 10.1016/j.diabet.2018.12.001PUB-30615985
Full text at the publisher
PubMed tag: none · 2019
Corrected
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.
Fonseca et al. 2019The Journal of clinical endocrinology and metabolismcited by 49
PMID 30938762DOI 10.1210/jc.2018-02685PUB-30938762
Rights unknown
PubMed tag: none · 2018
Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.
Petri et al. 2018Diabetes, obesity & metabolismcited by 47
PMID 29748996PMC6099226DOI 10.1111/dom.13358PUB-29748996
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2018
Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.
DeVries et al. 2018Diabetes, obesity & metabolismcited by 19
PMID 29862621PMC6175309DOI 10.1111/dom.13396PUB-29862621
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2018
Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
Carlsson Petri et al. 2018Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 43
PMID 29907893PMC6064581DOI 10.1007/s13300-018-0458-5PUB-29907893
Free to read · publisher termsCC BY-NC
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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