Primary outcomeLeast squares mean· Week 0, week 30
Change in HbA1c (Glycosylated Haemoglobin)
| Group | Value (percentage of glycosylated hemoglobin) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.45 | 0.09 |
| Semaglutide 1.0 mg | -1.85 | 0.09 |
| Placebo | -0.09 | 0.09 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy 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
Short name SUSTAIN™ 5
NCTNCT02305381 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3627Other id2013-004502-26Other idU1111-1149-3738Other idJapicCTI-142729
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 397 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
6 countries
United States, Germany, Japan, Puerto Rico, Serbia, Slovakia
- Start
- 1 Dec 2014
- Primary completion
- 21 Nov 2015
- Completion
- 21 Nov 2015
- First posted
- 2 Dec 2014 (estimated)
- Last update posted
- 11 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 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.
Interventions
- semaglutideDrug
- placeboDrug
Arms4
Experimental
Semaglutide 0.5 mg/Week
Experimental
Semaglutide 1.0 mg/Week
Placebo comparator
Semaglutide Placebo 0.5 mg/Week
Placebo comparator
Semaglutide Placebo 1.0 mg/Week
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 30
Registry description
Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Secondary outcomes(7)
Change in Body Weight
Time frame · Week 0, week 30
Registry description
Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Change in Fasting Plasma Glucose (FPG)
Time frame · week 0, week 30
Registry description
Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Change in Insulin Dose
Time frame · week 0, week 30
Registry description
Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.
Change in Systolic and Diastolic Blood Pressure
Time frame · week 0, week 30
Registry description
Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame · week 0, week 30
Registry description
The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result 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 post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] and use of metformin \[yes or no\]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.
HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
Time frame · After 30 weeks treatment
Registry description
Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target
Time frame · After 30 weeks treatment
Registry description
Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) 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(7)
Secondary outcomeLeast squares mean· Week 0, week 30
Change in Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -3.67 | 0.36 |
| Semaglutide 1.0 mg | -6.42 | 0.36 |
| Placebo | -1.36 | 0.37 |
Secondary outcomeLeast squares mean· week 0, week 30
Change in Fasting Plasma Glucose (FPG)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -29.14 | 3.74 |
| Semaglutide 1.0 mg | -42.38 | 3.76 |
| Placebo | -8.51 | 4.02 |
Secondary outcomeLeast squares mean· week 0, week 30
Change in Insulin Dose
| Group | Value (ratio) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | 0.90 | 0.01 |
| Semaglutide 1.0 mg | 0.85 | 0.01 |
| Placebo | 0.96 | 0.01 |
Secondary outcomeLeast squares mean· week 0, week 30
Change in Systolic and Diastolic Blood Pressure
| Group | Value (mm Hg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.84 | 0.73 |
| Semaglutide 1.0 mg | -1.50 | 0.74 |
| Placebo | -2.17 | 0.79 |
Secondary outcomeLeast squares mean· week 0, week 30
Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | 2.73 | 0.46 |
| Semaglutide 1.0 mg | 3.47 | 0.46 |
| Placebo | 1.25 | 0.50 |
Secondary outcomeNumber· After 30 weeks treatment
HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide 0.5 mg | 60.6 |
| Semaglutide 1.0 mg | 78.6 |
| Placebo | 10.5 |
Secondary outcomeNumber· After 30 weeks treatment
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide 0.5 mg | 40.9 |
| Semaglutide 1.0 mg | 61.1 |
| Placebo | 4.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5 mgSubjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. | – | 8 / 132 | 52 / 132 |
| Semaglutide 1.0 mgSubjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. | – | 12 / 131 | 54 / 131 |
| PlaceboSubjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. | – | 9 / 133 | 34 / 133 |
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
Studies10
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
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
8 results
Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial.
Rodbard et al. 2018The Journal of clinical endocrinology and metabolismcited by 315
PMID 29688502PMC5991220DOI 10.1210/jc.2018-00070PUB-29688502
CC BY8 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
More studies
4 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 · 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
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultRodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Diabetologia. 2016; 59: S364-5.
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, 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
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