Primary outcomeLeast squares mean· Week 0, week 30
Change in HbA1c From Baseline
| Group | Value (percentage) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | -1.21 | 0.05 |
| Semaglutide 1.0 mg/Week | -1.64 | 0.05 |
| Insulin Glargine | -0.83 | 0.05 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy 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
Short name SUSTAIN™ 4
NCTNCT02128932 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3625Other id2013-004392-12Other idU1111-1146-0211Other idNL47781.018.14
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 1,089 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
15 countries
United States, Argentina, Croatia, France, Germany, India, Mexico, Netherlands, North Macedonia, Puerto Rico, Romania, Slovakia, Slovenia, South Africa, United Kingdom
- Start
- 4 Aug 2014
- Primary completion
- 3 Sept 2015
- Completion
- 3 Sept 2015
- First posted
- 1 May 2014 (estimated)
- Last update posted
- 13 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 in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
Interventions
- semaglutideDrug
- insulin glargineDrug
Arms3
Experimental
Semaglutide 0.5 mg/week
Experimental
Semaglutide 1.0 mg/week
Active comparator
Insulin glargine
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline
Time frame · Week 0, week 30
Registry description
Change in HbA1c from baseline to week 30.
Secondary outcomes(7)
Change in Body Weight From Baseline
Time frame · Week 0, week 30
Registry description
Change in body weight from baseline to week 30.
Change in Fasting Plasma Glucose From Baseline
Time frame · Week 0, week 30
Registry description
Change in fasting plasma glucose from baseline to week 30.
Change in Diastolic Blood Pressure.
Time frame · Week 0, week 30
Registry description
Change in diastolic blood pressure from baseline to week 30.
Change in Systolic Blood Pressure.
Time frame · Week 0, week 30
Registry description
Change in systolic blood pressure from baseline to week 30.
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
Time frame · Week 0, week 30
Registry description
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Time frame · Week 0, week 30
Registry description
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Time frame · After 30 weeks treatment
Registry description
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
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(7)
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Body Weight From Baseline
| Group | Value (Kg) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | -3.47 | 0.24 |
| Semaglutide 1.0 mg/Week | -5.17 | 0.24 |
| Insulin Glargine | 1.15 | 0.23 |
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Fasting Plasma Glucose From Baseline
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | -36.74 | 2.14 |
| Semaglutide 1.0 mg/Week | -49.21 | 2.15 |
| Insulin Glargine | -38.18 | 2.03 |
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Diastolic Blood Pressure.
| Group | Value (mmHg) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | -1.38 | 0.43 |
| Semaglutide 1.0 mg/Week | -0.98 | 0.44 |
| Insulin Glargine | -1.44 | 0.41 |
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Systolic Blood Pressure.
| Group | Value (mmHg) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | -4.65 | 0.72 |
| Semaglutide 1.0 mg/Week | -5.17 | 0.73 |
| Insulin Glargine | -1.68 | 0.68 |
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
| Group | Value (T-scores) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | 0.95 | 0.51 |
| Semaglutide 1.0 mg/Week | 1.76 | 0.51 |
| Insulin Glargine | 0.90 | 0.48 |
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Semaglutide 0.5mg/Week | 4.86 | 0.28 |
| Semaglutide 1.0 mg/Week | 5.37 | 0.29 |
| Insulin Glargine | 3.99 | 0.27 |
Secondary outcomeNumber· After 30 weeks treatment
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
| Group | Value (Count of participants) |
|---|---|
| Semaglutide 0.5mg/Week | 135 |
| Semaglutide 1.0 mg/Week | 195 |
| Insulin Glargine | 63 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5mg/WeekSubjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | – | 22 / 362 | 172 / 362 |
| Semaglutide 1.0 mg/WeekSubjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | – | 17 / 360 | 192 / 360 |
| Insulin GlargineSubjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day | – | 18 / 360 | 107 / 360 |
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
Studies12
Studies that cite this trial.
Studies with results
7 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
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 · 2019
6 results
Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.
Jendle et al. 2019Diabetes, obesity & metabolismcited by 17
PMID 31215727PMC6771774DOI 10.1111/dom.13816PUB-31215727
Free to read · publisher termsCC BY-NC6 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
13 results
Efficacy 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 et al. 2017The lancet. Diabetes & endocrinologycited by 374
PMID 28344112DOI 10.1016/s2213-8587(17)30085-2PUB-28344112
Rights unknown13 results
Indexing hint: Randomized controlled trial · 2017
7 results
Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.
Kapitza et al. 2017Diabetologiacited by 97
PMID 28526920PMC5491562DOI 10.1007/s00125-017-4289-0PUB-28526920
CC BY7 results
More studies
5 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
Once-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 et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10
PMID 32193837PMC7193006DOI 10.1007/s13300-020-00796-zPUB-32193837
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 · 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
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or female, 18 years or older at the time of signing informed consent
* Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
* 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 of childbearing potential 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
* Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
* Treatment with any 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 (7 days or less in total) with insulin in connection with intercurrent illness
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value greater than or equal to 50 ng/L
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
* Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 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
* Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
PepBank is a research reference. Talk to a doctor before you use any peptide.