← Trials/Trial dossier/NCT01720446

SUSTAIN™ 6

CompletedPhase 3Results posted

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

253

Recruiting sites

—

Enrollment

3,297

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01720446

Org study IDNN9535-3744

Secondary ID2012-002839-28

Secondary IDU1111-1131-7227WHO

Timeline

Milestones

Study first posted2012-11-02estimated

Study start2013-02-21actual

Primary completion2016-03-15actual

Study completion2016-03-15actual

Results first posted2018-03-15actual

Last update posted2019-06-27actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Renal / kidney

Patient-reported / QoL

Cardiovascular outcomes

8 endpoints

Primary/registry result

Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide	6.6	—
Placebo	8.9	—

Hazard Ratio (HR)0.7495% CI0.58 – 0.95p<0.0001Regression, Cox

Hazard Ratio (HR)0.7495% CI0.58 – 0.95p0.0167Regression, Cox

Primary/protocol endpoint

Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/registry result

Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

Expanded / custom MACE composite

time to event, event

components3-point MACE, Coronary revascularization, Peripheral revascularization, Unstable angina hospitalization, Heart-failure hospitalization

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide	12.1	—
Placebo	16.0	—

Hazard Ratio (HR)0.7495% CI0.62 – 0.89p0.0016Regression, Cox

Secondary/registry result

Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

Expanded / custom MACE composite

time to event, event

components3-point MACE, Coronary revascularization, Peripheral revascularization, Unstable angina hospitalization, Heart-failure hospitalization

Posted result

Group	Value (number), percentage of subjects	95% CI
SemaglutideCardiovascular death	1.6	—
Non-fatal MI	2.5	—
Non-fatal Stroke	1.5	—
Revascularisation	2.6	—
UAP requiring hospitalisation	1.1	—
Hospitalisation for heart failure	2.7	—
PlaceboCardiovascular death	1.9	—
Non-fatal MI	3.7	—
Non-fatal Stroke	2.5	—
Revascularisation	4.2	—
UAP requiring hospitalisation	1.3	—
Hospitalisation for heart failure	2.4	—

Hazard Ratio (HR)0.9895% CI0.65 – 1.48p0.9181Regression, Cox

Hazard Ratio (HR)0.7495% CI0.51 – 1.08p0.1194Regression, Cox

Hazard Ratio (HR)0.6195% CI0.38 – 0.99p0.0438Regression, Cox

Hazard Ratio (HR)0.6595% CI0.50 – 0.86p0.0027Regression, Cox

Hazard Ratio (HR)0.8295% CI0.47 – 1.44p0.4914Regression, Cox

Hazard Ratio (HR)1.1195% CI0.77 – 1.61p0.5735Regression, Cox

Secondary/registry result

Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide	7.4	—
Placebo	9.6	—

Hazard Ratio (HR)0.7795% CI0.61 – 0.97p0.0292Regression, Cox

Secondary/protocol endpoint

Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

Expanded / custom MACE composite

time to event, event

components3-point MACE, Coronary revascularization, Peripheral revascularization, Unstable angina hospitalization, Heart-failure hospitalization

Secondary/protocol endpoint

Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

time to event, event

Secondary/protocol endpoint

Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke

Time frame:Time from randomisation up to end of follow-up (scheduled at week 109)

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight

Time frame:Week 0, up to week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Semaglutide 0.5 mg	-3.57	—
Semaglutide 1.0 mg	-4.88	—
Placebo	-0.62	—

Treatment difference-2.9595% CI-3.47 – -2.44p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Treatment difference-4.2795% CI-4.78 – -3.75p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight

Time frame:Week 0, up to week 104

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, up to week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated haemoglobin	95% CI
Semaglutide 0.5 mg	-1.09	—
Semaglutide 1.0 mg	-1.41	—
Placebo 0.5 mg	-0.44	—
Placebo 1.0 mg	-0.36	—

Treatment difference-0.6695% CI-0.80 – -0.52p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Treatment difference-1.0595% CI-1.19 – -0.91p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose

Time frame:Week 0, up to week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Semaglutide 0.5 mg	-1.75	—
Semaglutide 1.0 mg	-2.11	—
Placebo 0.5 mg	-1.02	—
Placebo 1.0 mg	-0.88	—

Treatment difference-0.7295% CI-1.06 – -0.38p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Treatment difference-1.2295% CI-1.56 – -0.88p<0.0001Mixed Models Analysis

Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, up to week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose

Time frame:Week 0, up to week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

2 endpoints

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio

Time frame:Week 0, up to week 104

uACR, change

ratio, improvement

LOINC 9318-7

Posted result

Group	Value (least_squares_mean), mg/g	95% CI
Semaglutide 0.5 mg	1.02	—
Semaglutide 1.0 mg	0.91	—
Placebo 0.5 mg	1.32	—
Placebo 1.0 mg	1.29	—

Treatment ratio0.7895% CI0.68 – 0.89p0.0003Mixed Models Analysis

Treatment ratio0.7195% CI0.62 – 0.81p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio

Time frame:Week 0, up to week 104

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile

Time frame:Week 0, up to week 104

ratio, improvement

componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, Triglycerides, change

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Semaglutide 0.5 mgTotal cholesterol (mg/dL)	0.97	—
HDL-cholesterol (mg/dL)	0.99	—
LDL-cholesterol (mg/dL)	0.97	—
Triglycerides (mg/dL)	0.93	—
Semaglutide 1.0 mgTotal cholesterol (mg/dL)	0.97	—
HDL-cholesterol (mg/dL)	1.01	—
LDL-cholesterol (mg/dL)	0.98	—
Triglycerides (mg/dL)	0.92	—
Placebo 0.5 mgTotal cholesterol (mg/dL)	1.00	—
HDL-cholesterol (mg/dL)	0.99	—
LDL-cholesterol (mg/dL)	1.01	—
Triglycerides (mg/dL)	0.96	—
Placebo 1.0 mgTotal cholesterol (mg/dL)	0.99	—
HDL-cholesterol (mg/dL)	0.97	—
LDL-cholesterol (mg/dL)	0.99	—
Triglycerides (mg/dL)	0.98	—

Treatment ratio0.9795% CI0.95 – 1.00p0.0149Mixed Models Analysis

Treatment ratio0.9995% CI0.97 – 1.01p0.2580Mixed Models Analysis

Treatment ratio1.0095% CI0.99 – 1.02p0.8106Mixed Models Analysis

Treatment ratio1.0495% CI1.02 – 1.06p<0.0001Mixed Models Analysis

Treatment ratio0.9695% CI0.93 – 0.99p0.0185Mixed Models Analysis

Treatment ratio0.9995% CI0.96 – 1.03p0.5996Mixed Models Analysis

Treatment ratio0.9795% CI0.93 – 1.01p0.1833Mixed Models Analysis

Treatment ratio0.9395% CI0.89 – 0.97p0.0009Mixed Models Analysis

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs

Time frame:Week 0, up to week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Semaglutide 0.5 mgDiastolic blood pressure (mmHg)	-1.37	—
Systolic blood pressure (mmHg)	-3.44	—
Semaglutide 1.0 mgDiastolic blood pressure (mmHg)	-1.57	—
Systolic blood pressure (mmHg)	-5.37	—
Placebo 0.5 mgDiastolic blood pressure (mmHg)	-1.42	—
Systolic blood pressure (mmHg)	-2.17	—
Placebo 1.0 mgDiastolic blood pressure (mmHg)	-1.71	—
Systolic blood pressure (mmHg)	-2.78	—

Treatment difference0.0495% CI-0.83 – 0.92p0.9205Mixed Models Analysis

Treatment difference0.1495% CI-0.74 – 1.03p0.7477Mixed Models Analysis

Treatment difference-1.2795% CI-2.77 – 0.23p0.0976Mixed Models Analysis

Treatment difference-2.5995% CI-4.09 – -1.08p0.0008Mixed Models Analysis

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)

Time frame:Week 0, up to week 104

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Semaglutide 0.5 mg	0.95	—
Semaglutide 1.0 mg	0.91	—
Placebo 0.5 mg	0.96	—
Placebo 1.0 mg	0.99	—

Treatment ratio0.9995% CI0.95 – 1.04p0.7796Mixed Models Analysis

Treatment ratio0.9295% CI0.88 – 0.96p0.0003Mixed Models Analysis

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)

Time frame:Week 0, up to week 104

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats/min	95% CI
Semaglutide 0.5 mg	2.12	—
Semaglutide 1.0 mg	2.41	—
Placebo 0.5 mg	0.09	—
Placebo 1.0 mg	-0.07	—

Treatment difference2.0295% CI1.07 – 2.98p<0.0001Mixed Models Analysis

Treatment difference2.4795% CI1.52 – 3.43p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile

Time frame:Week 0, up to week 104

ratio, improvement

componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, Triglycerides, change

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs

Time frame:Week 0, up to week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)

Time frame:Week 0, up to week 104

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)

Time frame:Week 0, up to week 104

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)

Time frame:Week 0, up to week 104

SF-36 total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Scores on a scale	95% CI
Semaglutide 0.5 mgBodily pain	0.66	—
General health	1.66	—
Mental component summary	0.0	—
Mental health	0.48	—
Physical component summary	0.76	—
Physical functioning	0.42	—
Role-emotional	0.17	—
Role-physical	0.39	—
Social functioning	-0.25	—
Vitality	0.29	—
Semaglutide 1.0 mgBodily pain	1.82	—
General health	2.55	—
Mental component summary	0.86	—
Mental health	1.08	—
Physical component summary	1.74	—
Physical functioning	1.12	—
Role-emotional	0.89	—
Role-physical	1.18	—
Social functioning	0.97	—
Vitality	1.55	—
Placebo 0.5 mgBodily pain	0.16	—
General health	0.78	—
Mental component summary	-0.17	—
Mental health	-0.14	—
Physical component summary	0.07	—
Physical functioning	-0.38	—
Role-emotional	-0.36	—
Role-physical	-0.33	—
Social functioning	-0.20	—
Vitality	-0.04	—
Placebo 1.0 mgBodily pain	0.35	—
General health	1.13	—
Mental component summary	-0.11	—
Mental health	-0.31	—
Physical component summary	0.35	—
Physical functioning	-0.37	—
Role-emotional	-0.05	—
Role-physical	0.03	—
Social functioning	-0.17	—
Vitality	0.35	—

Treatment difference0.5095% CI-0.48 – 1.47p0.3171Mixed Models Analysis

Treatment difference1.4795% CI0.50 – 2.45p0.0031Mixed Models Analysis

Treatment difference0.8795% CI0.06 – 1.69p0.0350Mixed Models Analysis

Treatment difference1.4295% CI0.60 – 2.24p0.0007Mixed Models Analysis

Treatment difference0.1795% CI-0.79 – 1.13p0.7277Mixed Models Analysis

Treatment difference0.9795% CI0.00 – 1.94p0.0489Mixed Models Analysis

Treatment Difference0.6195% CI-0.30 – 1.53p0.1860Mixed Models Analysis

Treatment difference1.3995% CI0.48 – 2.31p0.0029Mixed Models Analysis

Treatment difference0.6895% CI-0.09 – 1.45p0.0833Mixed Models Analysis

Treatment difference1.4095% CI0.62 – 2.17p0.0004Mixed Models Analysis

Treatment difference0.8095% CI-0.10 – 1.69p0.0799Mixed Models Analysis

Treatment difference1.5095% CI0.60 – 2.40p0.0011Mixed Models Analysis

Treatment difference0.5395% CI-0.63 – 1.68p0.3717Mixed Models Analysis

Treatment difference0.9495% CI-0.22 – 2.10p0.1136Mixed Models Analysis

Treatment difference0.7295% CI-0.24 – 1.67p0.1431Mixed Models Analysis

Treatment difference1.1495% CI0.18 – 2.11p0.0197Mixed Models Analysis

Treatment difference-0.0595% CI-1.03 – 0.93p0.9223Mixed Models Analysis

Treatment difference1.1495% CI0.15 – 2.13p0.0237Mixed Models Analysis

Treatment difference0.3395% CI-0.53 – 1.19p0.4523Mixed Models Analysis

Treatment difference1.2095% CI0.34 – 2.07p0.0064Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)

Time frame:Week 0, up to week 104

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events

Time frame:Week 0 - 109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Event rate per 100 exposure years	95% CI
Semaglutide 0.5 mg	37.5	—
Semaglutide 1.0 mg	36.2	—
Placebo 0.5 mg	35.3	—
Placebo 1.0 mg	39.7	—

Secondary/registry result

Incidence During the Trial in Other Treatment Outcomes: Adverse Events

Time frame:Weeks 0-109

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Event rate per 100 years of exposure	95% CI
Semaglutide 0.5 mg	330.5	—
Semaglutide 1.0 mg	337.0	—
Placebo 0.5 mg	317.4	—
Placebo 1.0 mg	298.3	—

Secondary/registry result

Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies

Time frame:Weeks 0-109

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), Percentage of subjects	95% CI
Semaglutide 0.5 mg	1.4	—
Semaglutide 1.0 mg	2.3	—

Secondary/protocol endpoint

Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events

Time frame:Week 0 - 109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Incidence During the Trial in Other Treatment Outcomes: Adverse Events

Time frame:Weeks 0-109

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies

Time frame:Weeks 0-109

Immunogenicity (ADA)

threshold achievement, event

Publications (24)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Semaglutide and Cardiovascular Outcomes in People with Type 2 Diabetes: A SUSTAIN-6 Post Hoc Analysis by Weight Loss Category.
Diabetes therapy : research, treatment and education of diabetes and related disorders2026 May 9PMID42105046doi:10.1007/s13300-026-01875-3via pubmed nct search
Effect of semaglutide versus placebo on cardiorenal outcomes by prior cardiovascular disease and baseline body mass index: Pooled post hoc analysis of SUSTAIN 6 and PIONEER 6.
Diabetes, obesity & metabolism2025 Oct (month)PMID40704485doi:10.1111/dom.16621via pubmed nct search
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6.
Diabetes therapy : research, treatment and education of diabetes and related disorders2025 Jan (month)PMID39520501doi:10.1007/s13300-024-01659-7via clinicaltrials gov reference derived + pubmed nct search
Effects of Once-Weekly Semaglutide on Kidney Disease Outcomes by KDIGO Risk Category in the SUSTAIN 6 Trial.
Kidney international reports2024 Jul (month)PMID39081763doi:10.1016/j.ekir.2024.04.028via pubmed nct search
Effect of semaglutide on major adverse cardiovascular events by baseline kidney parameters in participants with type 2 diabetes and at high risk of cardiovascular disease: SUSTAIN 6 and PIONEER 6 post hoc pooled analysis.
Cardiovascular diabetology2023 Aug 24PMID37620807doi:10.1186/s12933-023-01949-7via clinicaltrials gov reference derived + pubmed nct search
Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6.
Stroke2022 Sep (month)PMID35582947doi:10.1161/STROKEAHA.121.037775via clinicaltrials gov reference derived + pubmed nct search
Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease.
Diabetes, obesity & metabolism2022 Jul (month)PMID35332654doi:10.1111/dom.14700via clinicaltrials gov reference derived + pubmed nct search
Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6.
Cardiovascular diabetology2022 Apr 28PMID35484580doi:10.1186/s12933-022-01489-6via clinicaltrials gov reference derived + pubmed nct search
Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide.
Diabetes, obesity & metabolism2021 Jul (month)PMID33606902doi:10.1111/dom.14360via clinicaltrials gov reference derived + pubmed nct search
Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials.
Diabetes, obesity & metabolism2020 Dec (month)PMID32744418doi:10.1111/dom.14160via clinicaltrials gov reference derived + pubmed nct search
Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials.
Diabetes, obesity & metabolism2020 Nov (month)PMID32643857doi:10.1111/dom.14140via clinicaltrials gov reference derived + pubmed nct search
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials.
Diabetes, obesity & metabolism2020 Sep (month)PMID32372454doi:10.1111/dom.14079via clinicaltrials gov reference derived + pubmed nct search
Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6).
Diabetes, obesity & metabolism2020 Aug (month)PMID32227613doi:10.1111/dom.14039via clinicaltrials gov reference derived + pubmed nct search
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.
The Journal of clinical endocrinology and metabolism2020 Feb 1PMID31769496doi:10.1210/clinem/dgz072via clinicaltrials gov reference derived + pubmed nct search
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.
Diabetes & metabolism2019 Oct (month)PMID30615985doi:10.1016/j.diabet.2018.12.001via CT.gov reference
Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials.
Diabetes, obesity & metabolism2019 Jul (month)PMID30851070doi:10.1111/dom.13698via CT.gov background + pubmed nct search
Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial.
Cardiovascular diabetology2019 Jun 6PMID31167654doi:10.1186/s12933-019-0871-8via CT.gov reference + pubmed nct search
Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Aug (month)PMID29907893doi:10.1007/s13300-018-0458-5via CT.gov reference + pubmed nct search
Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.
The American journal of managed care2018 Apr (month)PMID29693361via clinicaltrials gov reference derived + pubmed nct search
Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.
Diabetes, obesity & metabolism2018 Apr (month)PMID29178519doi:10.1111/dom.13172via CT.gov reference
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
The New England journal of medicine2016 Nov 10PMID27633186doi:10.1056/NEJMoa1607141via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.