SUSTAIN 9

CompletedPhase 3Results posted

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

302

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT03086330

Org study IDNN9535-4269

Secondary ID2016-000904-27

Secondary IDJapicCTI-173542JAPIC

Secondary IDU1111-1180-1213WHO (World Health Organization)

Timeline

Milestones

Study start2017-03-15actual

Study first posted2017-03-22actual

Primary completion2018-07-04actual

Study completion2018-08-06actual

Results first posted2019-08-20actual

Last update posted2021-07-02actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent

•Diagnosed with type 2 diabetes mellitus

•HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)

•Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

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 measure as required by local regulation or practice)

•Any disorder 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 within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed

•Subjects with alanine aminotransferase above 2.5 x upper normal limit

•Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative

•History or presence of pancreatitis (acute or chronic)

•History of diabetic ketoacidosis

•Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening

•Subjects presently classified as being in New York Heart Association Class IV

•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

•Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening

•Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation

•Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Endpoints (116)

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

MASH / liver

Renal / kidney

Patient-reported / QoL

Other (unclassified)

Other clinical outcomes

Weight & body composition

14 endpoints

Secondary/registry result

Change in Body Weight (kg)

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Semaglutide 1.0 mg	-4.7	—
Placebo	-1.0	—

Treatment difference-3.8195% CI-4.70 – -2.93p<0.0001ANCOVA

Secondary/registry result

Change in Body Weight (%)

Time frame:Week 0, week 30

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage	95% CI
Semaglutide 1.0 mg	-5.4	—
Placebo	-1.0	—

Secondary/registry result

Change in Body Mass Index

Time frame:Week 0, week 30

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kg/sqm	95% CI
Semaglutide 1.0 mg	-1.7	—
Placebo	-0.4	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 30

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Semaglutide 1.0 mg	-4.4	—
Placebo	-1.8	—

Secondary/registry result/low confidence

Weight Loss Equal to or Above 3%

Time frame:After 30 weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	69.4	—
Placebo	21.1	—

Secondary/registry result

Weight Loss Equal to or Above 5%

Time frame:After 30 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	50.4	—
Placebo	7.8	—

Secondary/registry result

Weight Loss Equal to or Above 10%

Time frame:After 30 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	15.7	—
Placebo	1.6	—

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)

Time frame:Week 0, week 30

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Week 0, week 30

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 30

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Weight Loss Equal to or Above 3%

Time frame:After 30 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss Equal to or Above 5%

Time frame:After 30 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss Equal to or Above 10%

Time frame:After 30 weeks

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

22 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide 1.0 mg	-1.6	—
Placebo	-0.2	—

Treatment difference-1.4295% CI-1.61 – -1.24p<0.0001ANCOVA

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 1.0 mg	-2.26	—
Placebo	0.07	—

Secondary/registry result

Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 1.0 mg	-2.6	—
Placebo	-0.3	—

Secondary/registry result

Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 1.0 mg	-1.2	—
Placebo	0.0	—

Secondary/registry result

HbA1c Below 7.0% (53 mmol/Mol)

Time frame:After 30 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	82.5	—
Placebo	20.5	—

Secondary/registry result

HbA1c Equal to or Below 6.5% (48 mmol/Mol)

Time frame:After 30 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	60.0	—
Placebo	3.9	—

Secondary/registry result

HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 30 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	72.5	—
Placebo	17.3	—

Secondary/registry result

HbA1c Reduction Equal to or Above 1%-Point

Time frame:After 30 weeks

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	80.8	—
Placebo	15.0	—

Secondary/registry result

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	56.7	—
Placebo	7.9	—

Secondary/registry result/low confidence

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	41.7	—
Placebo	4.7	—

Secondary/registry result

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	15.0	—
Placebo	1.6	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

HbA1c Below 7.0% (53 mmol/Mol)

Time frame:After 30 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Equal to or Below 6.5% (48 mmol/Mol)

Time frame:After 30 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 30 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Reduction Equal to or Above 1%-Point

Time frame:After 30 weeks

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, weight responder 3pct

Secondary/protocol endpoint

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint/low confidence

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%

Time frame:After 30 weeks

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

MASH / liver

6 endpoints

Secondary/registry result/low confidence

Change in Biochemistry: Alkaline Phosphatase

Time frame:Week 0, week 30

change from baseline, improvement

Posted result

Group	Value (geometric_mean), U/L	95% CI
Semaglutide 1.0 mg	4.6	—
Placebo	7.2	—

Secondary/registry result

Change in Biochemistry: Alanine Aminotransferase

Time frame:Week 0, week 30

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Value (geometric_mean), U/L	95% CI
Semaglutide 1.0 mg	4.5	—
Placebo	4.8	—

Secondary/registry result

Change in Biochemistry: Aspartate Aminotransferase

Time frame:Week 0, week 30

AST, change

change from baseline, improvement

LOINC 1920-8

Posted result

Group	Value (geometric_mean), U/L	95% CI
Semaglutide 1.0 mg	3.4	—
Placebo	3.5	—

Secondary/protocol endpoint

Change in Biochemistry: Alkaline Phosphatase

Time frame:Week 0, week 30

change from baseline, improvement

Secondary/protocol endpoint

Change in Biochemistry: Alanine Aminotransferase

Time frame:Week 0, week 30

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Biochemistry: Aspartate Aminotransferase

Time frame:Week 0, week 30

AST, change

change from baseline, improvement

LOINC 1920-8

Renal / kidney

5 endpoints

Secondary/registry result

Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)

Time frame:Week 0, week 30

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (geometric_mean), mL/min/1.73m2	95% CI
Semaglutide 1.0 mg	3.4	—
Placebo	3.2	—

Secondary/registry result

Change in Biochemistry: Creatinine

Time frame:Week 0, week 30

change from baseline, improvement

Posted result

Group	Value (geometric_mean), umol/L	95% CI
Semaglutide 1.0 mg	4.6	—
Placebo	2.6	—

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Albumin

Time frame:Week 0, week 30

change from baseline, improvement

Secondary/protocol endpoint

Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)

Time frame:Week 0, week 30

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in Biochemistry: Creatinine

Time frame:Week 0, week 30

change from baseline, improvement

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Change in Fasting Blood Lipid, Total Cholesterol

Time frame:Week 0, week 30

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Semaglutide 1.0 mg	0.91	—
Placebo	1.02	—

Secondary/registry result

Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 30

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Semaglutide 1.0 mg	0.90	—
Placebo	1.04	—

Secondary/registry result

Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol

Time frame:Week 0, week 30

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Semaglutide 1.0 mg	0.99	—
Placebo	1.01	—

Secondary/registry result

Change in Fasting Blood Lipid, Triglycerides

Time frame:Week 0, week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Semaglutide 1.0 mg	0.81	—
Placebo	0.97	—

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Week 0, week 30

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 1.0 mg	-4.3	—
Placebo	1.1	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Week 0, week 30

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 1.0 mg	-0.1	—
Placebo	-0.1	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/min	95% CI
Semaglutide 1.0 mg	4.0	—
Placebo	0.1	—

Secondary/protocol endpoint

Change in Fasting Blood Lipid, Total Cholesterol

Time frame:Week 0, week 30

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 30

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol

Time frame:Week 0, week 30

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Blood Lipid, Triglycerides

Time frame:Week 0, week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Week 0, week 30

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Week 0, week 30

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Time frame:Week 0, week 30

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Semaglutide 1.0 mgPhysical component summary	1.9	—
1) Physical functioning	1.3	—
2) Role functioning	1.5	—
3) Bodily pain	0.9	—
4) General health	2.7	—
Mental component summary	0.1	—
5) Vitality	1.5	—
6) Social functioning	0.3	—
7) Role emotional	0.1	—
8) Mental health	0.5	—
PlaceboPhysical component summary	0.7	—
1) Physical functioning	1.1	—
2) Role functioning	0.0	—
3) Bodily pain	0.1	—
4) General health	0.1	—
Mental component summary	-0.9	—
5) Vitality	0.2	—
6) Social functioning	-1.0	—
7) Role emotional	-0.2	—
8) Mental health	-0.6	—

Secondary/registry result

Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately

Time frame:Week 0, week 30

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Semaglutide 1.0 mg1) Feeling of unacceptably high blood sugars	-2.2	—
2) Feeling of unacceptably low blood sugars	0.3	—
Total treatment satisfaction score (Sum of 3-8)	4.2	—
3) Satisfaction with current treatment	0.8	—
4) Convenience of current treatment	0.7	—
5) Flexibility of current treatment	0.7	—
6) Satisfaction with understanding of diabetes	0.5	—
7) Recommending treatment to others	0.8	—
8) Satisfaction to continue with present treatment	0.8	—
Placebo1) Feeling of unacceptably high blood sugars	-0.8	—
2) Feeling of unacceptably low blood sugars	-0.4	—
Total treatment satisfaction score (Sum of 3-8)	1.9	—
3) Satisfaction with current treatment	0.2	—
4) Convenience of current treatment	0.5	—
5) Flexibility of current treatment	0.4	—
6) Satisfaction with understanding of diabetes	0.5	—
7) Recommending treatment to others	0.2	—
8) Satisfaction to continue with present treatment	0.2	—

Secondary/protocol endpoint

Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Time frame:Week 0, week 30

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately

Time frame:Week 0, week 30

change from baseline, improvement

Safety / tolerability / PK

46 endpoints

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Week 0 - week 30

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 1.0 mg	356	—
Placebo	247	—

Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 - week 30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 1.0 mg	4	—
Placebo	0	—

Secondary/registry result

Change in Haematology: Haemoglobin

Time frame:Week 0, week 30

haemoglobin change

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), mmol/L	95% CI
Semaglutide 1.0 mg	1.1	—
Placebo	1.1	—

Secondary/registry result

Change in Haematology: Haematocrit

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), % of red blood cells	95% CI
Semaglutide 1.0 mg	1.4	—
Placebo	1.1	—

Secondary/registry result

Change in Haematology: Thrombocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), 10^9 thrombocytes/L	95% CI
Semaglutide 1.0 mg	25.3	—
Placebo	20.2	—

Secondary/registry result

Change in Haematology: Erythrocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), 10^12 erythrocytes/L	95% CI
Semaglutide 1.0 mg	0.16	—
Placebo	0.11	—

Secondary/registry result

Change in Haematology: Leucocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), 10^9 leucocytes/L	95% CI
Semaglutide 1.0 mg	0.65	—
Placebo	0.54	—

Secondary/registry result

Change in Biochemistry: Amylase

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), U/L	95% CI
Semaglutide 1.0 mg	10.2	—
Placebo	5.0	—

Secondary/registry result

Change in Biochemistry: Lipase

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), U/L	95% CI
Semaglutide 1.0 mg	11.6	—
Placebo	4.5	—

Secondary/registry result

Change in Biochemistry: Total Bilirubin

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), umol/L	95% CI
Semaglutide 1.0 mg	2.3	—
Placebo	1.7	—

Secondary/registry result

Change in Biochemistry: Albumin

Time frame:Week 0, week 30

albumin serum

change from baseline, descriptive

LOINC 1751-7

Posted result

Group	Value (geometric_mean), g/dL	95% CI
Semaglutide 1.0 mg	0.1	—
Placebo	0.1	—

Secondary/registry result

Change in Biochemistry: Calcium (Total)

Time frame:Week 0, week 30

change from baseline, descriptive

LOINC 17861-6

Posted result

Group	Value (geometric_mean), mmol/L	95% CI
Semaglutide 1.0 mg	0.04	—
Placebo	0.05	—

Secondary/registry result

Change in Biochemistry: Potassium

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), mmol/L	95% CI
Semaglutide 1.0 mg	0.3	—
Placebo	0.2	—

Secondary/registry result

Change in Biochemistry: Bicarbonate

Time frame:Week 0, week 30

serum bicarbonate

change from baseline, descriptive

LOINC 1963-8

Posted result

Group	Value (geometric_mean), mmol/L	95% CI
Semaglutide 1.0 mg	2.2	—
Placebo	2.1	—

Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 30

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), ng/L	95% CI
Semaglutide 1.0 mg	1.3	—
Placebo	1.7	—

Secondary/registry result

Change in Electrocardiogram

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek 0: Normal	62.4	—
Week 0: Abnormal, NCS	36.9	—
Week 0: Abnormal, CS	0.7	—
Week 30: Normal	64.3	—
Week 30: Abnormal, NCS	34.9	—
Week 30: Abnormal, CS	0.8	—
PlaceboWeek 0: Normal	66.2	—
Week 0: Abnormal, NCS	32.5	—
Week 0: Abnormal, CS	1.3	—
Week 30: Normal	66.4	—
Week 30: Abnormal, NCS	32.2	—
Week 30: Abnormal, CS	1.4	—

Secondary/registry result

Change in Physical Examination: General Appearance

Time frame:Week -2, week 30

categorical status, descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	90.0	—
Week -2: Abnormal, NCS	10.0	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	87.6	—
Week 30: Abnormal, NCS	11.6	—
Week 30: Abnormal, CS	0.8	—
PlaceboWeek -2: Normal	86.0	—
Week -2: Abnormal, NCS	14.0	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	87.1	—
Week 30: Abnormal, NCS	12.2	—
Week 30: Abnormal, CS	0.7	—

Secondary/registry result

Change in Physical Examination: Central and Peripheral Nervous System

Time frame:Week -2, week 30

categorical status, descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	92.0	—
Week -2: Abnormal, NCS	7.3	—
Week -2: Abnormal, CS	0.7	—
Week 30: Normal	94.2	—
Week 30: Abnormal, NCS	5.0	—
Week 30: Abnormal, CS	0.8	—
PlaceboWeek -2: Normal	86.7	—
Week -2: Abnormal, NCS	12.7	—
Week -2: Abnormal, CS	0.7	—
Week 30: Normal	87.8	—
Week 30: Abnormal, NCS	12.2	—
Week 30: Abnormal, CS	0	—

Secondary/registry result

Change in Physical Examination: Cardiovascular System

Time frame:Week -2, week 30

descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	98.7	—
Week -2: Abnormal, NCS	1.3	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	98.3	—
Week 30: Abnormal, NCS	1.7	—
Week 30: Abnormal, CS	0	—
PlaceboWeek -2: Normal	93.3	—
Week -2: Abnormal, NCS	6.0	—
Week -2: Abnormal, CS	0.7	—
Week 30: Normal	92.8	—
Week 30: Abnormal, NCS	7.2	—
Week 30: Abnormal, CS	0	—

Secondary/registry result

Change in Physical Examination: Gastrointestinal System Including Mouth

Time frame:Week -2, week 30

categorical status, descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	93.3	—
Week -2: Abnormal, NCS	6.7	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	95.9	—
Week 30: Abnormal, NCS	3.3	—
Week 30: Abnormal, CS	0.8	—
PlaceboWeek -2: Normal	93.3	—
Week -2: Abnormal, NCS	6.7	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	94.2	—
Week 30: Abnormal, NCS	5.8	—
Week 30: Abnormal, CS	0	—

Secondary/registry result

Change in Physical Examination: Skin

Time frame:Week -2, week 30

descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	91.3	—
Week -2: Abnormal, NCS	8.7	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	93.4	—
Week 30: Abnormal, NCS	6.6	—
Week 30: Abnormal, CS	0	—
PlaceboWeek -2: Normal	93.3	—
Week -2: Abnormal, NCS	6.7	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	95.0	—
Week 30: Abnormal, NCS	4.3	—
Week 30: Abnormal, CS	0.7	—

Secondary/registry result

Change in Physical Examination: Respiratory System

Time frame:Week -2, week 30

descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	100	—
Week -2: Abnormal, NCS	0	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	100	—
Week 30: Abnormal, NCS	0	—
Week 30: Abnormal, CS	0	—
PlaceboWeek -2: Normal	98.7	—
Week -2: Abnormal, NCS	1.3	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	99.3	—
Week 30: Abnormal, NCS	0.7	—
Week 30: Abnormal, CS	0	—

Secondary/registry result

Change in Physical Examination: Lymph Node Palpation

Time frame:Week -2, week 30

descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	99.3	—
Week -2: Abnormal, NCS	0.7	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	99.2	—
Week 30: Abnormal, NCS	0	—
Week 30: Abnormal, CS	0.8	—
PlaceboWeek -2: Normal	100	—
Week -2: Abnormal, NCS	0	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	100	—
Week 30: Abnormal, NCS	0	—
Week 30: Abnormal, CS	0	—

Secondary/registry result

Change in Physical Examination: Thyroid Gland

Time frame:Week -2, week 30

Thyroid event

categorical status, event

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgWeek -2: Normal	98.0	—
Week -2: Abnormal, NCS	2.0	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	99.2	—
Week 30: Abnormal, NCS	0.8	—
Week 30: Abnormal, CS	0	—
PlaceboWeek -2: Normal	96.7	—
Week -2: Abnormal, NCS	3.3	—
Week -2: Abnormal, CS	0	—
Week 30: Normal	97.1	—
Week 30: Abnormal, NCS	2.9	—
Week 30: Abnormal, CS	0	—

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Week 0 - week 30

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 - week 30

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change in Haematology: Haemoglobin

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Haematocrit

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Thrombocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Erythrocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Leucocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Amylase

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Lipase

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Total Bilirubin

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Calcium (Total)

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Potassium

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Calcitonin

Time frame:Week 0, week 30

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change in Electrocardiogram

Time frame:Week 0, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: General Appearance

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: Central and Peripheral Nervous System

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: Cardiovascular System

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: Gastrointestinal System Including Mouth

Time frame:Week -2, week 30

descriptive

Secondary/protocol endpoint

Change in Physical Examination: Skin

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: Respiratory System

Time frame:Week -2, week 30

descriptive

Secondary/protocol endpoint

Change in Physical Examination: Lymph Node Palpation

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination: Thyroid Gland

Time frame:Week -2, week 30

categorical status, event

Other clinical outcomes

2 endpoints

Secondary/registry result/low confidence

Change in Fundoscopy

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mgLeft eye: Week 0; normal	70.7	—
Left eye: Week 0; abnormal, NCS	24.7	—
Left eye: Week 0; abnormal, CS	4.7	—
Left eye: Week 30; normal	79.3	—
Left eye: Week 30; abnormal, NCS	17.1	—
Left eye: Week 30; abnormal, CS	3.7	—
Right eye: Week 0; normal	69.3	—
Right eye: Week 0; abnormal, NCS	25.3	—
Right eye: Week 0; abnormal, CS	5.3	—
Right eye: Week 30; normal	75.6	—
Right eye: Week 30; abnormal, NCS	19.5	—
Right eye: Week 30; abnormal, CS	4.9	—
PlaceboLeft eye: Week 0; normal	62.0	—
Left eye: Week 0; abnormal, NCS	32.7	—
Left eye: Week 0; abnormal, CS	5.3	—
Left eye: Week 30; normal	64.1	—
Left eye: Week 30; abnormal, NCS	31.5	—
Left eye: Week 30; abnormal, CS	4.3	—
Right eye: Week 0; normal	62.4	—
Right eye: Week 0; abnormal, NCS	30.9	—
Right eye: Week 0; abnormal, CS	6.7	—
Right eye: Week 30; normal	63.7	—
Right eye: Week 30; abnormal, NCS	31.9	—
Right eye: Week 30; abnormal, CS	4.4	—

Secondary/protocol endpoint

Change in Fundoscopy

Time frame:Week 0, week 30

categorical status, descriptive

Other (unclassified)

3 endpoints

Secondary/registry result/low confidence

Change in Biochemistry: Sodium

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

Group	Value (geometric_mean), mmol/L	95% CI
Semaglutide 1.0 mg	1.7	—
Placebo	1.5	—

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Sodium

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Bicarbonate

Time frame:Week 0, week 30

change from baseline, descriptive

Publications (1)

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 once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.
The lancet. Diabetes & endocrinology2019 May (month)PMID30833170doi:10.1016/S2213-8587(19)30066-Xvia 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.