← Trials/Trial dossier/NCT03136484

SUSTAIN 8

CompletedPhase 3Results posted

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

119

Recruiting sites

—

Enrollment

788

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 IDNCT03136484

Org study IDNN9535-4270

Secondary ID2016-000989-35

Secondary IDU1111-1180-3651World Health Organization (WHO)

Timeline

Milestones

Study start2017-03-15actual

Study first posted2017-05-02actual

Primary completion2018-10-16actual

Study completion2018-11-16actual

Results first posted2019-12-17actual

Last update posted2020-01-21actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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, age equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - 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) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - 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 (DKA) - Any of the following: myocardial infarction (MI), 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 (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - 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 - 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 - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening

Endpoints (122)

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

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

MASH / liver

Renal / kidney

Other (unclassified)

Other clinical outcomes

Weight & body composition

28 endpoints

Secondary/registry result

Change in Body Weight (kg)

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide + Canagliflozin Placebo	-5.7	—
Canagliflozin + Semaglutide Placebo	-4.3	—

Secondary/registry result

Change in Total Fat Mass (kg)

Time frame:Week 0, week 52

Total fat mass

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Semaglutide + Canagliflozin Placebo	-3.72	—
Canagliflozin + Semaglutide Placebo	-2.63	—

Secondary/registry result

Percentage Change in Body Weight (%)

Time frame:Week 0, week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide + Canagliflozin Placebo	-6.2	—
Canagliflozin + Semaglutide Placebo	-4.7	—

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 52

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per square meter (kg/m^2)	95% CI
Semaglutide + Canagliflozin Placebo	-2.0	—
Canagliflozin + Semaglutide Placebo	-1.5	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide + Canagliflozin Placebo	-4.2	—
Canagliflozin + Semaglutide Placebo	-3.0	—

Secondary/registry result

Percentage Change in Total Fat Mass (%)

Time frame:Week 0, week 52

Total fat mass

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide + Canagliflozin Placebo	-1.55	—
Canagliflozin + Semaglutide Placebo	-1.21	—

Secondary/registry result

Change in Total Lean Mass (kg)

Time frame:Week 0, week 52

Lean mass

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Semaglutide + Canagliflozin Placebo	-2.06	—
Canagliflozin + Semaglutide Placebo	-1.53	—

Secondary/registry result

Percentage Change in Total Lean Mass (%)

Time frame:Week 0, week 52

Lean mass

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide + Canagliflozin Placebo	1.38	—
Canagliflozin + Semaglutide Placebo	1.09	—

Secondary/registry result

Change in Visceral Fat Mass (kg)

Time frame:Week 0, week 52

Visceral fat, change

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Semaglutide + Canagliflozin Placebo	-0.20	—
Canagliflozin + Semaglutide Placebo	-0.13	—

Secondary/registry result

Percentage Change in Visceral Fat Mass (%)

Time frame:Week 0, week 52

Visceral fat, change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide + Canagliflozin Placebo	-0.81	—
Canagliflozin + Semaglutide Placebo	0.16	—

Secondary/registry result

Change in Ratio Between Total Fat Mass and Total Lean Mass

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), total fat mass/total lean mass ratio	95% CI
Semaglutide + Canagliflozin Placebo	-0.04	—
Canagliflozin + Semaglutide Placebo	-0.03	—

Secondary/registry result

Participants Who Achieved Weight Loss ≥3% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	68.8	—
No	31.2	—
Canagliflozin + Semaglutide PlaceboYes	64.9	—
No	35.1	—

Secondary/registry result

Participants Who Achieved Weight Loss ≥5% (Yes/no)

Time frame:Week 0, week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	52.7	—
No	47.3	—
Canagliflozin + Semaglutide PlaceboYes	47.0	—
No	53.0	—

Secondary/registry result

Participants Who Achieved Weight Loss ≥10% (Yes/no)

Time frame:Week 0, week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	23.2	—
No	76.8	—
Canagliflozin + Semaglutide PlaceboYes	8.9	—
No	91.1	—

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Fat Mass (kg)

Time frame:Week 0, week 52

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Body Weight (%)

Time frame:Week 0, week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Total Fat Mass (%)

Time frame:Week 0, week 52

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Total Lean Mass (kg)

Time frame:Week 0, week 52

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Total Lean Mass (%)

Time frame:Week 0, week 52

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Mass (kg)

Time frame:Week 0, week 52

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Visceral Fat Mass (%)

Time frame:Week 0, week 52

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Ratio Between Total Fat Mass and Total Lean Mass

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieved Weight Loss ≥3% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieved Weight Loss ≥5% (Yes/no)

Time frame:Week 0, week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieved Weight Loss ≥10% (Yes/no)

Time frame:Week 0, week 52

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

22 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage (%) of HbA1c	95% CI
Semaglutide + Canagliflozin PlaceboOn-treatment without rescue medication	-1.7	—
In-trial	-1.5	—
Canagliflozin + Semaglutide PlaceboOn-treatment without rescue medication	-1.0	—
In-trial	-1.0	—

Treatment difference-0.4995% CI-0.65 – -0.33p<.0001ANCOVA

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in FPG (Fasting Plasma Glucose)

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Semaglutide + Canagliflozin Placebo	-2.54	—
Canagliflozin + Semaglutide Placebo	-2.00	—

Secondary/registry result

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

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide + Canagliflozin Placebo	-2.8	—
Canagliflozin + Semaglutide Placebo	-1.9	—

Secondary/registry result

Change in SMPG- Mean Postprandial Increment Over All Meals

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide + Canagliflozin Placebo	-0.6	—
Canagliflozin + Semaglutide Placebo	-0.6	—

Secondary/registry result

Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	76.1	—
No	23.9	—
Canagliflozin + Semaglutide PlaceboYes	50.8	—
No	49.2	—

Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	62.1	—
No	37.9	—
Canagliflozin + Semaglutide PlaceboYes	26.8	—
No	73.2	—

Secondary/registry result

Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	76.5	—
No	23.5	—
Canagliflozin + Semaglutide PlaceboYes	48.6	—
No	51.4	—

Secondary/registry result

Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

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

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	69.6	—
No	30.4	—
Canagliflozin + Semaglutide PlaceboYes	45.0	—
No	55.0	—

Secondary/registry result

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	57.3	—
No	42.7	—
Canagliflozin + Semaglutide PlaceboYes	34.8	—
No	65.2	—

Secondary/registry result

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	45.1	—
No	54.9	—
Canagliflozin + Semaglutide PlaceboYes	25.9	—
No	74.1	—

Secondary/registry result

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide + Canagliflozin PlaceboYes	21.8	—
No	78.2	—
Canagliflozin + Semaglutide PlaceboYes	6.1	—
No	93.9	—

Secondary/protocol endpoint

Change in FPG (Fasting Plasma Glucose)

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in SMPG- Mean Postprandial Increment Over All Meals

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)

Time frame:Week 0, week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Secondary/protocol endpoint

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)

Time frame:Week 0, week 52

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

MASH / liver

5 endpoints

Secondary/registry result

Change in Biochemistry Parameter- ALT

Time frame:Week 0, week 52

ALT, change

ratio, improvement

LOINC 1742-6

Posted result

Group	Value (geometric_mean), Ratio of ALT	95% CI
Semaglutide + Canagliflozin Placebo	0.79	—
Canagliflozin + Semaglutide Placebo	0.79	—

Secondary/registry result

Change in Biochemistry Parameter- AST

Time frame:Week 0, week 52

AST, change

ratio, improvement

LOINC 1920-8

Posted result

Group	Value (geometric_mean), Ratio of AST	95% CI
Semaglutide + Canagliflozin Placebo	0.89	—
Canagliflozin + Semaglutide Placebo	0.86	—

Secondary/registry result

Change in Biochemistry Parameter- ALP

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of ALP	95% CI
Semaglutide + Canagliflozin Placebo	0.96	—
Canagliflozin + Semaglutide Placebo	0.95	—

Secondary/protocol endpoint

Change in Biochemistry Parameter- ALT

Time frame:Week 0, week 52

ALT, change

ratio, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Biochemistry Parameter- AST

Time frame:Week 0, week 52

AST, change

ratio, improvement

LOINC 1920-8

Renal / kidney

5 endpoints

Secondary/registry result

Change in Biochemistry Parameter- Creatinine

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of creatinine	95% CI
Semaglutide + Canagliflozin Placebo	1.03	—
Canagliflozin + Semaglutide Placebo	1.04	—

Secondary/registry result

Change in Biochemistry Parameter- eGFR

Time frame:Week 0, week 52

eGFR, change

ratio, improvement

LOINC 98979-8

Posted result

Group	Value (geometric_mean), Ratio of eGFR	95% CI
Semaglutide + Canagliflozin Placebo	0.98	—
Canagliflozin + Semaglutide Placebo	0.96	—

Secondary/registry result/low confidence

Change in Biochemistry Parameter- Albumin

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of albumin	95% CI
Semaglutide + Canagliflozin Placebo	0.99	—
Canagliflozin + Semaglutide Placebo	1.00	—

Secondary/protocol endpoint

Change in Biochemistry Parameter- Creatinine

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint

Change in Biochemistry Parameter- eGFR

Time frame:Week 0, week 52

eGFR, change

ratio, improvement

LOINC 98979-8

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Change in Fasting Total Cholesterol

Time frame:Week 0, week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide + Canagliflozin Placebo	0.96	—
Canagliflozin + Semaglutide Placebo	1.03	—

Secondary/registry result

Change in Fasting LDL-cholesterol

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL-cholesterol	95% CI
Semaglutide + Canagliflozin Placebo	0.96	—
Canagliflozin + Semaglutide Placebo	1.05	—

Secondary/registry result

Change in Fasting HDL-cholesterol

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL-cholesterol	95% CI
Semaglutide + Canagliflozin Placebo	1.04	—
Canagliflozin + Semaglutide Placebo	1.08	—

Secondary/registry result

Change in Fasting Triglycerides

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide + Canagliflozin Placebo	0.86	—
Canagliflozin + Semaglutide Placebo	0.92	—

Secondary/registry result

Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)

Time frame:Week 0, week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Semaglutide + Canagliflozin PlaceboSystolic blood pressure	-3.7	—
Diastolic blood pressure	-1.2	—
Canagliflozin + Semaglutide PlaceboSystolic blood pressure	-5.8	—
Diastolic blood pressure	-2.9	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Semaglutide + Canagliflozin Placebo	2.7	—
Canagliflozin + Semaglutide Placebo	-0.6	—

Secondary/protocol endpoint

Change in Fasting Total Cholesterol

Time frame:Week 0, week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting LDL-cholesterol

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting HDL-cholesterol

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Triglycerides

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)

Time frame:Week 0, week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

12 endpoints

Secondary/registry result

Change in Short Form 36 Health Survey (SF-36): Sub-domains

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin PlaceboPhysical Functioning	1.9	—
Role-physical	1.8	—
Bodily pain	2.5	—
General health	3.7	—
Social functioning	1.1	—
Role-emotional	0.8	—
Vitality	3.0	—
Mental health	1.5	—
Canagliflozin + Semaglutide PlaceboPhysical Functioning	2.7	—
Role-physical	2.0	—
Bodily pain	1.5	—
General health	3.5	—
Social functioning	1.1	—
Role-emotional	1.2	—
Vitality	2.0	—
Mental health	0.6	—

Secondary/registry result

Change in SF-36: Physical Component Summary (PCS)

Time frame:Week 0, week 52

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin Placebo	2.7	—
Canagliflozin + Semaglutide Placebo	2.9	—

Secondary/registry result

Change in SF-36: Mental Component Summary (MCS)

Time frame:Week 0, week 52

SF-36 mental

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin Placebo	1.1	—
Canagliflozin + Semaglutide Placebo	0.5	—

Secondary/registry result

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin Placebo1) Satisfaction with treatment	1.4	—
2) Feeling of unacceptably high blood sugars	-2.0	—
3) Feeling of unacceptably low blood sugars	0.1	—
4) Convenience of treatment	0.8	—
5) Flexibility of current treatment	0.8	—
6) Satisfaction with understanding of diabetes	0.8	—
7) Recommending treatment to others	0.9	—
8) Satisfaction to continue with present treatment	1.1	—
Total treatment satisfaction score	5.8	—
Canagliflozin + Semaglutide Placebo1) Satisfaction with treatment	1.0	—
2) Feeling of unacceptably high blood sugars	-1.8	—
3) Feeling of unacceptably low blood sugars	0.1	—
4) Convenience of treatment	0.7	—
5) Flexibility of current treatment	0.7	—
6) Satisfaction with understanding of diabetes	0.6	—
7) Recommending treatment to others	0.9	—
8) Satisfaction to continue with present treatment	0.8	—
Total treatment satisfaction score	4.8	—

Secondary/registry result

Change in Control of Eating Questionnaire (CoEQ): Domains

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin PlaceboCraving control	1.0	—
Craving for sweet	-0.6	—
Craving for savoury	-1.1	—
Positive mood	0.7	—
Canagliflozin + Semaglutide PlaceboCraving control	1.0	—
Craving for sweet	-0.6	—
Craving for savoury	-0.9	—
Positive mood	0.4	—

Secondary/registry result

Change in CoEQ: Individual Items

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide + Canagliflozin PlaceboHow hungry have you felt	-1.2	—
How full have you felt	0.2	—
How often have you had cravings (last 7 days)	-0.9	—
How strong have any cravings been	-0.9	—
Difficulty to resist cravings	-0.9	—
Ate in response to cravings	-0.9	—
Difficulty to control eating	-1.5	—
Desire to eat savory food	-1.4	—
Craving for dairy foods	-0.8	—
Craving for starchy foods	-1.4	—
Craving for savory foods	-0.9	—
Desire to eat sweet food	-0.9	—
Craving for chocolate	-0.3	—
Craving for other sweets	-0.6	—
Craving for fruit or fruit juice	-0.6	—
Felt happy	0.8	—
Felt anxious	-0.9	—
Felt alert	0.2	—
Felt contented	0.8	—
Canagliflozin + Semaglutide PlaceboHow hungry have you felt	-0.8	—
How full have you felt	0.0	—
How often have you had cravings (last 7 days)	-1.1	—
How strong have any cravings been	-1.1	—
Difficulty to resist cravings	-0.8	—
Ate in response to cravings	-0.7	—
Difficulty to control eating	-1.2	—
Desire to eat savory food	-1.0	—
Craving for dairy foods	-0.6	—
Craving for starchy foods	-1.1	—
Craving for savory foods	-0.9	—
Desire to eat sweet food	-1.0	—
Craving for chocolate	-0.4	—
Craving for other sweets	-0.6	—
Craving for fruit or fruit juice	-0.6	—
Felt happy	0.4	—
Felt anxious	-0.6	—
Felt alert	0.0	—
Felt contented	0.5	—

Secondary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36): Sub-domains

Time frame:Week 0, week 52

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Physical Component Summary (PCS)

Time frame:Week 0, week 52

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Mental Component Summary (MCS)

Time frame:Week 0, week 52

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

Time frame:Week 0, week 52

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Control of Eating Questionnaire (CoEQ): Domains

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: Individual Items

Time frame:Week 0, week 52

change from baseline, improvement

Safety / tolerability / PK

32 endpoints

Secondary/registry result

Total Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-57

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse events	95% CI
Semaglutide + Canagliflozin Placebo	1189	—
Canagliflozin + Semaglutide Placebo	1138	—

Secondary/registry result

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haemoglobin	95% CI
Semaglutide + Canagliflozin Placebo	0.99	—
Canagliflozin + Semaglutide Placebo	1.05	—

Secondary/registry result

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haematocrit	95% CI
Semaglutide + Canagliflozin Placebo	0.99	—
Canagliflozin + Semaglutide Placebo	1.04	—

Secondary/registry result

Change in Haematological Parameter- Erythrocytes

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of erythrocytes	95% CI
Semaglutide + Canagliflozin Placebo	0.99	—
Canagliflozin + Semaglutide Placebo	1.04	—

Secondary/registry result

Change in Haematological Parameter- Leukocytes

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of leukocytes	95% CI
Semaglutide + Canagliflozin Placebo	0.97	—
Canagliflozin + Semaglutide Placebo	0.98	—

Secondary/registry result

Change in Haematological Parameter- Thrombocytes

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of thrombocytes	95% CI
Semaglutide + Canagliflozin Placebo	1.04	—
Canagliflozin + Semaglutide Placebo	1.00	—

Secondary/registry result

Change in Biochemistry Parameter- Amylase

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Semaglutide + Canagliflozin Placebo	1.16	—
Canagliflozin + Semaglutide Placebo	1.09	—

Secondary/registry result

Change in Biochemistry Parameter- Lipase

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Semaglutide + Canagliflozin Placebo	1.25	—
Canagliflozin + Semaglutide Placebo	1.01	—

Secondary/registry result

Change in Biochemistry Parameter- Total Bilirubin

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of total bilirubin	95% CI
Semaglutide + Canagliflozin Placebo	1.06	—
Canagliflozin + Semaglutide Placebo	1.13	—

Secondary/registry result

Change in Biochemistry Parameter- Calcium

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcium	95% CI
Semaglutide + Canagliflozin Placebo	1.01	—
Canagliflozin + Semaglutide Placebo	1.02	—

Secondary/registry result

Change in Biochemistry Parameter- Potassium

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of potassium	95% CI
Semaglutide + Canagliflozin Placebo	1.00	—
Canagliflozin + Semaglutide Placebo	1.00	—

Secondary/registry result

Change in Biochemistry Parameter- Sodium

Time frame:Week 0, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of sodium	95% CI
Semaglutide + Canagliflozin Placebo	1.00	—
Canagliflozin + Semaglutide Placebo	1.00	—

Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 52

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Semaglutide + Canagliflozin Placebo	1.08	—
Canagliflozin + Semaglutide Placebo	1.04	—

Secondary/registry result

Change in ECG

Time frame:Week 0, week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide + Canagliflozin PlaceboNormal (week 0)	263	—
Abnormal NCS (week 0)	126	—
Abnormal CS (week 0)	3	—
Normal (week 52)	222	—
Abnormal NCS (week 52)	109	—
Abnormal CS (week 52)	0	—
Canagliflozin + Semaglutide PlaceboNormal (week 0)	277	—
Abnormal NCS (week 0)	117	—
Abnormal CS (week 0)	0	—
Normal (week 52)	242	—
Abnormal NCS (week 52)	95	—
Abnormal CS (week 52)	3	—

Secondary/registry result

Change in Physical Examination

Time frame:Week -2, week 52

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide + Canagliflozin PlaceboGeneral Appearance (week -2) Normal	345	—
General Appearance (week -2) Abnormal NCS	46	—
General Appearance (week -2) Abnormal CS	1	—
General Appearance (week 52) Normal	294	—
General Appearance (week 52) Abnormal NCS	30	—
General Appearance (week 52) Abnormal CS	2	—
Nervous System (week -2) Normal	360	—
Nervous System (week -2) Abnormal NCS	26	—
Nervous System (week -2) Abnormal CS	5	—
Nervous System (week 52) Normal	303	—
Nervous System (week 52) Abnormal NCS	21	—
Nervous System (week 52) Abnormal CS	2	—
Cardiovascular System (week-2) Normal	376	—
Cardiovascular System (week -2) Abnormal NCS	15	—
Cardiovascular System (week -2) Abnormal CS	1	—
Cardiovascular System (week52) Normal	318	—
Cardiovascular System (week 52) Abnormal NCS	7	—
Cardiovascular System (week 52) Abnormal CS	1	—
Gastrointestinal System (week -2) Normal	369	—
Gastrointestinal System (week -2) Abnormal NCS	22	—
Gastrointestinal System (week -2) Abnormal CS	1	—
Gastrointestinal System (week 52) Normal	319	—
Gastrointestinal System (week 52) Abnormal NCS	7	—
Gastrointestinal System (week 52) Abnormal CS	0	—
Skin (week -2) Normal	330	—
Skin (week -2) Abnormal NCS	62	—
Skin (week -2) Abnormal CS	0	—
Skin (week 52) Normal	286	—
Skin (week 52) Abnormal NCS	39	—
Skin (week 52) Abnormal CS	1	—
Respiratory System (week -2) Normal	383	—
Respiratory System (week -2) Abnormal NCS	7	—
Respiratory System (week -2) Abnormal CS	2	—
Respiratory System (week 52) Normal	321	—
Respiratory System (week 52) Abnormal NCS	4	—
Respiratory System (week 52) Abnormal CS	1	—
Lymph Node Palpation (week -2) Normal	390	—
Lymph Node Palpation (week -2) Abnormal NCS	1	—
Lymph Node Palpation (week -2) Abnormal CS	0	—
Lymph Node Palpation (week 52) Normal	325	—
Lymph Node Palpation (week 52) Abnormal NCS	0	—
Lymph Node Palpation (week 52) Abnormal CS	0	—
Thyroid Gland (week -2) Normal	390	—
Thyroid Gland (week -2) Abnormal NCS	2	—
Thyroid Gland (week -2) Abnormal CS	0	—
Thyroid Gland (week 52) Normal	326	—
Thyroid Gland (week 52) Abnormal NCS	0	—
Thyroid Gland (week 52) Abnormal CS	0	—
Left foot (week -2) Normal	343	—
Left foot (week -2) Abnormal NCS	47	—
Left foot (week -2) Abnormal CS	2	—
Left foot (week 52) Normal	293	—
Left foot (week 52) Abnormal NCS	32	—
Left foot (week 52) Abnormal CS	1	—
Right foot (week -2) Normal	344	—
Right foot (week -2) Abnormal NCS	45	—
Right foot (week -2) Abnormal CS	3	—
Right foot (week 52) Normal	289	—
Right foot (week 52) Abnormal NCS	34	—
Right foot (week 52) Abnormal CS	3	—
Left leg (week -2) Normal	348	—
Left leg (week -2) Abnormal NCS	40	—
Left leg (week -2) Abnormal CS	4	—
Left leg (week 52) Normal	300	—
Left leg (week 52) Abnormal NCS	22	—
Left leg (week 52) Abnormal CS	4	—
Right leg (week -2) Normal	350	—
Right leg (week -2) Abnormal NCS	37	—
Right leg (week -2) Abnormal CS	5	—
Right leg (week 52) Normal	301	—
Right leg (week 52) Abnormal NCS	19	—
Right leg (week 52) Abnormal CS	6	—
Canagliflozin + Semaglutide PlaceboGeneral Appearance (week -2) Normal	335	—
General Appearance (week -2) Abnormal NCS	56	—
General Appearance (week -2) Abnormal CS	3	—
General Appearance (week 52) Normal	304	—
General Appearance (week 52) Abnormal NCS	33	—
General Appearance (week 52) Abnormal CS	2	—
Nervous System (week -2) Normal	370	—
Nervous System (week -2) Abnormal NCS	21	—
Nervous System (week -2) Abnormal CS	3	—
Nervous System (week 52) Normal	325	—
Nervous System (week 52) Abnormal NCS	12	—
Nervous System (week 52) Abnormal CS	2	—
Cardiovascular System (week-2) Normal	386	—
Cardiovascular System (week -2) Abnormal NCS	8	—
Cardiovascular System (week -2) Abnormal CS	0	—
Cardiovascular System (week52) Normal	333	—
Cardiovascular System (week 52) Abnormal NCS	6	—
Cardiovascular System (week 52) Abnormal CS	0	—
Gastrointestinal System (week -2) Normal	377	—
Gastrointestinal System (week -2) Abnormal NCS	16	—
Gastrointestinal System (week -2) Abnormal CS	1	—
Gastrointestinal System (week 52) Normal	331	—
Gastrointestinal System (week 52) Abnormal NCS	8	—
Gastrointestinal System (week 52) Abnormal CS	0	—
Skin (week -2) Normal	323	—
Skin (week -2) Abnormal NCS	69	—
Skin (week -2) Abnormal CS	2	—
Skin (week 52) Normal	298	—
Skin (week 52) Abnormal NCS	40	—
Skin (week 52) Abnormal CS	1	—
Respiratory System (week -2) Normal	391	—
Respiratory System (week -2) Abnormal NCS	3	—
Respiratory System (week -2) Abnormal CS	0	—
Respiratory System (week 52) Normal	336	—
Respiratory System (week 52) Abnormal NCS	3	—
Respiratory System (week 52) Abnormal CS	0	—
Lymph Node Palpation (week -2) Normal	392	—
Lymph Node Palpation (week -2) Abnormal NCS	2	—
Lymph Node Palpation (week -2) Abnormal CS	0	—
Lymph Node Palpation (week 52) Normal	337	—
Lymph Node Palpation (week 52) Abnormal NCS	0	—
Lymph Node Palpation (week 52) Abnormal CS	0	—
Thyroid Gland (week -2) Normal	390	—
Thyroid Gland (week -2) Abnormal NCS	4	—
Thyroid Gland (week -2) Abnormal CS	0	—
Thyroid Gland (week 52) Normal	337	—
Thyroid Gland (week 52) Abnormal NCS	1	—
Thyroid Gland (week 52) Abnormal CS	0	—
Left foot (week -2) Normal	345	—
Left foot (week -2) Abnormal NCS	44	—
Left foot (week -2) Abnormal CS	5	—
Left foot (week 52) Normal	303	—
Left foot (week 52) Abnormal NCS	34	—
Left foot (week 52) Abnormal CS	2	—
Right foot (week -2) Normal	348	—
Right foot (week -2) Abnormal NCS	42	—
Right foot (week -2) Abnormal CS	4	—
Right foot (week 52) Normal	304	—
Right foot (week 52) Abnormal NCS	32	—
Right foot (week 52) Abnormal CS	3	—
Left leg (week -2) Normal	358	—
Left leg (week -2) Abnormal NCS	30	—
Left leg (week -2) Abnormal CS	6	—
Left leg (week 52) Normal	314	—
Left leg (week 52) Abnormal NCS	22	—
Left leg (week 52) Abnormal CS	3	—
Right leg (week -2) Normal	357	—
Right leg (week -2) Abnormal NCS	30	—
Right leg (week -2) Abnormal CS	7	—
Right leg (week 52) Normal	315	—
Right leg (week 52) Abnormal NCS	21	—
Right leg (week 52) Abnormal CS	3	—

Secondary/registry result

Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide + Canagliflozin Placebo	25	—
Canagliflozin + Semaglutide Placebo	6	—

Secondary/registry result

Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Participants	95% CI
Semaglutide + Canagliflozin Placebo	6	—
Canagliflozin + Semaglutide Placebo	5	—

Secondary/protocol endpoint

Total Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-57

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Leukocytes

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Thrombocytes

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Amylase

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Lipase

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Calcium

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Potassium

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Sodium

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Calcitonin

Time frame:Week 0, week 52

Thyroid event

ratio, descriptive

Secondary/protocol endpoint

Change in ECG

Time frame:Week 0, week 52

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week -2, week 52

categorical status, descriptive

Secondary/protocol endpoint

Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Other clinical outcomes

2 endpoints

Secondary/registry result

Eye Examination

Time frame:Week 0, week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide + Canagliflozin PlaceboLeft eye: Normal (week 0)	322	—
Left eye: Abnormal NCS (week 0)	65	—
Left eye: Abnormal CS (week 0)	5	—
Left eye: Normal (week 52)	231	—
Left eye: Abnormal NCS (week 52)	30	—
Left eye: Abnormal CS (week 52)	7	—
Right eye: Normal (week 0)	321	—
Right eye: Abnormal NCS (week 0)	66	—
Right eye: Abnormal CS (week 0)	5	—
Right eye: Normal (week 52)	225	—
Right eye: Abnormal NCS (week 52)	35	—
Right eye: Abnormal CS (week 52)	8	—
Canagliflozin + Semaglutide PlaceboLeft eye: Normal (week 0)	319	—
Left eye: Abnormal NCS (week 0)	71	—
Left eye: Abnormal CS (week 0)	3	—
Left eye: Normal (week 52)	228	—
Left eye: Abnormal NCS (week 52)	40	—
Left eye: Abnormal CS (week 52)	2	—
Right eye: Normal (week 0)	319	—
Right eye: Abnormal NCS (week 0)	70	—
Right eye: Abnormal CS (week 0)	4	—
Right eye: Normal (week 52)	226	—
Right eye: Abnormal NCS (week 52)	44	—
Right eye: Abnormal CS (week 52)	0	—

Secondary/protocol endpoint

Eye Examination

Time frame:Week 0, week 52

categorical status, descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change in Haematological Parameter- Erythrocytes

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter- ALP

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter- Total Bilirubin

Time frame:Week 0, week 52

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter- Albumin

Time frame:Week 0, week 52

ratio, descriptive

Publications (6)

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

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
Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study.
PharmacoEconomics - open2023 Jul (month)PMID37178435doi:10.1007/s41669-023-00416-zvia clinicaltrials gov reference derived + pubmed nct search
Cost-Effectiveness of Once-Weekly Semaglutide 1 mg versus Canagliflozin 300 mg in Patients with Type 2 Diabetes Mellitus in a Canadian Setting.
Applied health economics and health policy2022 Jul (month)PMID35344191doi:10.1007/s40258-022-00726-zvia pubmed nct search
Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.
The Journal of clinical endocrinology and metabolism2020 Dec 1PMID32827435doi:10.1210/clinem/dgaa577via clinicaltrials gov reference derived + pubmed nct search
Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial.
Diabetologia2020 Mar (month)PMID31897524doi:10.1007/s00125-019-05065-8via CT.gov reference + pubmed nct search
Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial.
The lancet. Diabetes & endocrinology2019 Nov (month)PMID31540867doi:10.1016/S2213-8587(19)30311-0via 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.