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SUSTAIN 7

CompletedPhase 3Results posted

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Dulaglutide / Semaglutide

Listed sites

209

Recruiting sites

—

Enrollment

1,201

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

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 IDNCT02648204

Org study IDNN9535-4216

Secondary ID2014-005375-91

Secondary IDU1111-1164-8495WHO

Timeline

Milestones

Study first posted2016-01-06estimated

Study start2016-01-06actual

Primary completion2017-04-10actual

Study completion2017-05-19actual

Results first posted2018-05-08actual

Last update posted2019-10-15actual

Assets

Investigational agents

Dulaglutide Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening 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 (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Endpoints (56)

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

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

12 endpoints

Secondary/registry result

Change in Body Weight (kg)

Time frame:Week 0, week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Semaglutide 0.5 mg	-4.56	—
Semaglutide 1.0 mg	-6.53	—
Dulaglutide 0.75 mg	-2.30	—
Dulaglutide 1.5 mg	-2.98	—

Treatment difference-2.2695% CI-3.02 – -1.51p<0.0001Mixed Models Analysis

Treatment difference-3.5595% CI-4.32 – -2.78p<0.0001Mixed Models Analysis

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 40

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m^2	95% CI
Semaglutide 0.5 mg	-1.63	—
Semaglutide 1.0 mg	-2.33	—
Dulaglutide 0.75 mg	-0.82	—
Dulaglutide 1.5 mg	-1.08	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 40

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Semaglutide 0.5 mg	-4.27	—
Semaglutide 1.0 mg	-5.20	—
Dulaglutide 0.75 mg	-2.36	—
Dulaglutide 1.5 mg	-2.93	—

Secondary/registry result

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%

Time frame:After 40 weeks treatment

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	43.9	—
No	56.1	—
Semaglutide 1.0 mgYes	63.0	—
No	37.0	—
Dulaglutide 0.75 mgYes	22.7	—
No	77.3	—
Dulaglutide 1.5 mgYes	30.2	—
No	69.8	—

Secondary/registry result

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%

Time frame:After 40 weeks treatment

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	14.3	—
No	85.7	—
Semaglutide 1.0 mgYes	26.7	—
No	73.3	—
Dulaglutide 0.75 mgYes	3.3	—
No	96.7	—
Dulaglutide 1.5 mgYes	7.7	—
No	92.3	—

Secondary/registry result/low confidence

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%

Time frame:After 40 weeks treatment

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	64.5	—
No	35.5	—
Semaglutide 1.0 mgYes	76.7	—
No	23.3	—
Dulaglutide 0.75 mgYes	36.5	—
No	63.5	—
Dulaglutide 1.5 mgYes	44.6	—
No	55.4	—

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Week 0, week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, week 40

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 40

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%

Time frame:After 40 weeks treatment

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%

Time frame:After 40 weeks treatment

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%

Time frame:After 40 weeks treatment

threshold achievement, improvement

Glycemic / diabetes

18 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Semaglutide 0.5 mg	-1.51	—
Semaglutide 1.0 mg	-1.78	—
Dulaglutide 0.75 mg	-1.11	—
Dulaglutide 1.5 mg	-1.37	—

Treatment difference-0.4095% CI-0.55 – -0.25p<0.0001Mixed Models Analysis

Treatment difference-0.4195% CI-0.57 – -0.25p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose

Time frame:Week 0, week 40

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	-2.18	—
Semaglutide 1.0 mg	-2.83	—
Dulaglutide 0.75 mg	-1.87	—
Dulaglutide 1.5 mg	-2.25	—

Secondary/registry result

HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target

Time frame:After 40 weeks treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	49.2	—
No	50.8	—
Semaglutide 1.0 mgYes	66.7	—
No	33.3	—
Dulaglutide 0.75 mgYes	34.1	—
No	65.9	—
Dulaglutide 1.5 mgYes	47.2	—
No	52.8	—

Secondary/registry result

Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile

Time frame:Week 0, week 40

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Semaglutide 0.5 mg	-2.43	—
Semaglutide 1.0 mg	-2.95	—
Dulaglutide 0.75 mg	-1.99	—
Dulaglutide 1.5 mg	-2.32	—

Secondary/registry result

Change From Baseline 7-point Self-measured Plasma Glucose Increment

Time frame:Week 0, week 40

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Semaglutide 0.5 mg	-0.77	—
Semaglutide 1.0 mg	-0.93	—
Dulaglutide 0.75 mg	-0.44	—
Dulaglutide 1.5 mg	-0.63	—

Secondary/registry result

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target

Time frame:After 40 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	68.4	—
No	31.6	—
Semaglutide 1.0 mgYes	78.7	—
No	21.3	—
Dulaglutide 0.75 mgYes	52.2	—
No	47.8	—
Dulaglutide 1.5 mgYes	66.6	—
No	33.4	—

Secondary/registry result

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 40 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	64.5	—
No	35.5	—
Semaglutide 1.0 mgYes	74.0	—
No	26.0	—
Dulaglutide 0.75 mgYes	44.1	—
No	55.9	—
Dulaglutide 1.5 mgYes	58.4	—
No	41.6	—

Secondary/registry result

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%

Time frame:After 40 weeks of treatment

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	77.4	—
No	22.6	—
Semaglutide 1.0 mgYes	83.3	—
No	16.7	—
Dulaglutide 0.75 mgYes	53.8	—
No	46.2	—
Dulaglutide 1.5 mgYes	67.6	—
No	32.4	—

Secondary/registry result/low confidence

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%

Time frame:After 40 weeks treatment

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mgYes	53.2	—
No	46.8	—
Semaglutide 1.0 mgYes	68.3	—
No	31.7	—
Dulaglutide 0.75 mgYes	25.1	—
No	74.9	—
Dulaglutide 1.5 mgYes	34.9	—
No	65.1	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Week 0, week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target

Time frame:After 40 weeks treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile

Time frame:Week 0, week 40

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline 7-point Self-measured Plasma Glucose Increment

Time frame:Week 0, week 40

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target

Time frame:After 40 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 40 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%

Time frame:After 40 weeks of treatment

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%

Time frame:After 40 weeks treatment

threshold achievement, improvement

componentsHbA1c, % change, Body weight, % change

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Change in Systolic and Diastolic Blood Pressure

Time frame:Week 0, week 40

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Semaglutide 0.5 mgDiastolic BP	-0.57	—
Systolic BP	-2.44	—
Semaglutide 1.0 mgDiastolic BP	-2.05	—
Systolic BP	-4.88	—
Dulaglutide 0.75 mgDiastolic BP	-0.35	—
Systolic BP	-2.16	—
Dulaglutide 1.5 mgDiastolic BP	-0.03	—
Systolic BP	-2.86	—

Secondary/registry result

Change in Fasting Blood Lipids (Total Cholesterol)

Time frame:Week 0, week 40

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	0.96	—
Semaglutide 1.0 mg	0.97	—
Dulaglutide 0.75 mg	0.97	—
Dulaglutide 1.5 mg	0.99	—

Secondary/registry result

Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)

Time frame:Week 0, week 40

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	0.97	—
Semaglutide 1.0 mg	1.00	—
Dulaglutide 0.75 mg	0.97	—
Dulaglutide 1.5 mg	1.01	—

Secondary/registry result

Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)

Time frame:Week 0, week 40

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	0.99	—
Semaglutide 1.0 mg	1.01	—
Dulaglutide 0.75 mg	1.00	—
Dulaglutide 1.5 mg	1.02	—

Secondary/registry result

Change in Fasting Blood Lipids (Triglycerides)

Time frame:Week 0, week 40

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	0.91	—
Semaglutide 1.0 mg	0.86	—
Dulaglutide 0.75 mg	0.91	—
Dulaglutide 1.5 mg	0.90	—

Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 40

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats/min	95% CI
Semaglutide 0.5 mg	2.09	—
Semaglutide 1.0 mg	3.96	—
Dulaglutide 0.75 mg	1.56	—
Dulaglutide 1.5 mg	2.42	—

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure

Time frame:Week 0, week 40

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in Fasting Blood Lipids (Total Cholesterol)

Time frame:Week 0, week 40

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)

Time frame:Week 0, week 40

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)

Time frame:Week 0, week 40

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Blood Lipids (Triglycerides)

Time frame:Week 0, week 40

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 40

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire

Time frame:Week 0, week 40

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
Semaglutide 0.5 mg	4.60	—
Semaglutide 1.0 mg	4.55	—
Dulaglutide 0.75 mg	4.52	—
Dulaglutide 1.5 mg	4.65	—

Secondary/registry result

Change in Short Form Health Survey (SF-36v2™)

Time frame:Week 0, week 40

SF-36 total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
Semaglutide 0.5 mgPhysical component summary	1.21	—
Mental component summary	1.45	—
Physical functioning	1.25	—
Role-physical	0.98	—
Bodily pain	0.96	—
General health	2.65	—
Vitality	1.23	—
Social functioning	1.18	—
Role-emotional	1.11	—
Mental health	1.89	—
Semaglutide 1.0 mgPhysical component summary	2.04	—
Mental component summary	1.23	—
Physical functioning	2.00	—
Role-physical	2.03	—
Bodily pain	1.54	—
General health	2.52	—
Vitality	1.97	—
Social functioning	0.83	—
Role-emotional	1.57	—
Mental health	1.65	—
Dulaglutide 0.75 mgPhysical component summary	1.93	—
Mental component summary	0.95	—
Physical functioning	2.17	—
Role-physical	1.39	—
Bodily pain	1.69	—
General health	1.86	—
Vitality	2.14	—
Social functioning	0.78	—
Role-emotional	1.04	—
Mental health	1.43	—
Dulaglutide 1.5 mgPhysical component summary	1.29	—
Mental component summary	1.08	—
Physical functioning	1.05	—
Role-physical	0.82	—
Bodily pain	0.77	—
General health	2.73	—
Vitality	1.83	—
Social functioning	0.63	—
Role-emotional	1.08	—
Mental health	0.96	—

Secondary/protocol endpoint

Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire

Time frame:Week 0, week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form Health Survey (SF-36v2™)

Time frame:Week 0, week 40

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

10 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:40 weeks + follow-up of 5 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Semaglutide 0.5 mg	966	—
Semaglutide 1.0 mg	1015	—
Dulaglutide 0.75 mg	802	—
Dulaglutide 1.5 mg	957	—

Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:40 weeks + follow-up of 5 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), hypoglycaemic episodes	95% CI
Semaglutide 0.5 mg	3	—
Semaglutide 1.0 mg	7	—
Dulaglutide 0.75 mg	3	—
Dulaglutide 1.5 mg	5	—

Secondary/registry result

Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:40 weeks + follow-up of 5 weeks

Documented hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), percentage of subjects	95% CI
Semaglutide 0.5 mg	0.7	—
Semaglutide 1.0 mg	1.7	—
Dulaglutide 0.75 mg	1.0	—
Dulaglutide 1.5 mg	1.7	—

Secondary/registry result

Change in Amylase

Time frame:Week 0, week 40

ratio, descriptive

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	1.17	—
Semaglutide 1.0 mg	1.22	—
Dulaglutide 0.75 mg	1.16	—
Dulaglutide 1.5 mg	1.20	—

Secondary/registry result

Change in Lipase

Time frame:Week 0, week 40

ratio, descriptive

Posted result

Group	Value (geometric_least_squares_mean), ratio to baseline	95% CI
Semaglutide 0.5 mg	1.22	—
Semaglutide 1.0 mg	1.32	—
Dulaglutide 0.75 mg	1.23	—
Dulaglutide 1.5 mg	1.29	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:40 weeks + follow-up of 5 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:40 weeks + follow-up of 5 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:40 weeks + follow-up of 5 weeks

Documented hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change in Amylase

Time frame:Week 0, week 40

change from baseline, descriptive

Secondary/protocol endpoint

Change in Lipase

Time frame:Week 0, week 40

change from baseline, descriptive

Publications (13)

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

Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison.
Diabetes research and clinical practice2024 Jun (month)PMID38777128doi:10.1016/j.diabres.2024.111717via clinicaltrials gov reference derived + pubmed nct search
Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses.
BMJ open2020 Nov 16PMID33199417doi:10.1136/bmjopen-2020-037883via 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
Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada.
PharmacoEconomics - open2019 Dec (month)PMID30927241doi:10.1007/s41669-019-0131-6via CT.gov background
Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.
Diabetes, obesity & metabolism2019 Oct (month)PMID31215727doi:10.1111/dom.13816via 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
The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia.
Advances in therapy2019 Aug (month)PMID31168765doi:10.1007/s12325-019-00965-yvia CT.gov background
GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2019 Jun (month)PMID30865526doi:10.4158/EP-2018-0444via CT.gov background
Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK.
Diabetes, obesity & metabolism2019 Mar (month)PMID30362224doi:10.1111/dom.13564via CT.gov reference
Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.
Current medical research and opinion2018 Sep (month)PMID29764222doi:10.1080/03007995.2018.1476332via CT.gov reference
Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Jun (month)PMID29557057doi:10.1007/s13300-018-0402-8via CT.gov reference
Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
The lancet. Diabetes & endocrinology2018 Apr (month)PMID29397376doi:10.1016/S2213-8587(18)30024-Xvia CT.gov reference + pubmed nct search
Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
Diabetes care2018 Feb (month)PMID29246950doi:10.2337/dc17-0417via CT.gov reference

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.