← Trials/Trial dossier/NCT03191396

SUSTAIN 10

CompletedPhase 3Results posted

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

92

Recruiting sites

Enrollment

577

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-11%

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 IDNCT03191396
Org study IDNN9535-4339
Secondary ID2016-004965-22EudraCT
Secondary IDU1111-1190-5868World Health Organization (WHO)

Timeline

Milestones

Study first posted2017-06-19actual
Study start2017-06-27actual
Primary completion2018-07-09actual
Study completion2018-08-13actual
Results first posted2019-08-28actual
Last update posted2019-10-15actual

Assets

Investigational agents

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 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening:
a)Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record).
b)Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record).
c)SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - 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 (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit 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

Endpoints (82)

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
22
Safety / tolerability / PK
21
Weight & body composition
14
Cardiometabolic biomarkers
14
Renal / kidney
5
Patient-reported / QoL
4
MASH / liver
2

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

GroupValue (mean), kg95% CI
Semaglutide 1.0 mg-5.8
Liraglutide 1.2 mg-2.0
Treatment difference-3.8395% CI-4.57-3.09p<0.0001ANCOVA
Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 30

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kg/sqm95% CI
Semaglutide 1.0 mg-2.0
Liraglutide 1.2 mg-0.7
Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 30

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), cm95% CI
Semaglutide 1.0 mg-5.2
Liraglutide 1.2 mg-2.4
Secondary/registry result

Change in Body Weight (%)

Time frame:Week 0, week 30

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage of body weight95% CI
Semaglutide 1.0 mg-6.1
Liraglutide 1.2 mg-2.0
Secondary/registry result

Subjects Who Achieve Weight Loss Above or Equal to 3%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Semaglutide 1.0 mg72.7
Liraglutide 1.2 mg33.9
Secondary/registry result

Subjects Who Achieve Weight Loss Above or Equal to 5%

Time frame:After 30 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg55.9
Liraglutide 1.2 mg17.7
Secondary/registry result

Subjects Who Achieve Weight Loss Above or Equal to 10%

Time frame:After 30 weeks of treatment

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg19.1
Liraglutide 1.2 mg4.4
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 Mass Index (BMI)

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

Change in Body Weight (%)

Time frame:Week 0, week 30

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Subjects Who Achieve Weight Loss Above or Equal to 3%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who Achieve Weight Loss Above or Equal to 5%

Time frame:After 30 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who Achieve Weight Loss Above or Equal to 10%

Time frame:After 30 weeks of treatment

≥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

GroupValue (mean), Percentage of glycosylated haemoglobin95% CI
Semaglutide 1.0 mg-1.7
Liraglutide 1.2 mg-1.1
Treatment difference-0.6995% CI-0.82-0.56p<0.0001ANCOVA
Treatment difference-0.6995% CI-0.82-0.56p<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

GroupValue (mean), mmol/L95% CI
Semaglutide 1.0 mg-2.65
Liraglutide 1.2 mg-1.46
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

GroupValue (mean), mmol/L95% CI
Semaglutide 1.0 mg-3.0
Liraglutide 1.2 mg-2.1
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

GroupValue (mean), mmol/L95% CI
Semaglutide 1.0 mg-1.0
Liraglutide 1.2 mg-0.4
Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target

Time frame:After 30 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Semaglutide 1.0 mg80.4
Liraglutide 1.2 mg45.9
Secondary/registry result

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target

Time frame:After 30 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Semaglutide 1.0 mg58.5
Liraglutide 1.2 mg24.8
Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 30 weeks of treatment

threshold achievement, improvement

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

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg75.6
Liraglutide 1.2 mg36.8
Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg82.8
Liraglutide 1.2 mg48.3
Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg62.4
Liraglutide 1.2 mg20.9
Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg49.6
Liraglutide 1.2 mg11.9
Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 1.0 mg17.1
Liraglutide 1.2 mg3.6
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

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target

Time frame:After 30 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target

Time frame:After 30 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Time frame:After 30 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

Time frame:After 30 weeks of treatment

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%

Time frame:After 30 weeks of treatment

threshold achievement, improvement

componentsHbA1c, change, ≥10% weight-loss responders

MASH / liver

2 endpoints
Secondary/registry result

Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.

Time frame:Week 0, week 30

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

GroupValue (geometric_mean), mmol/L95% CI
Semaglutide 1.0 mgAlkaline phosphatase5.5
Alanine Aminotransferase5.3
Aspartate Aminotransferase3.5
Liraglutide 1.2 mgAlkaline phosphatase6.4
Alanine Aminotransferase5.0
Aspartate Aminotransferase3.1
Secondary/protocol endpoint

Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.

Time frame:Week 0, week 30

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

5 endpoints
Secondary/registry result/low confidence

Change in Biochemistry - Albumin

Time frame:Week 0, week 30

change from baseline, improvement

Posted result

GroupValue (geometric_mean), g/dL95% CI
Semaglutide 1.0 mg0.2
Liraglutide 1.2 mg0.2
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

GroupValue (geometric_mean), mL/min/1.73m295% CI
Semaglutide 1.0 mg4.0
Liraglutide 1.2 mg4.1
Secondary/protocol endpoint/low confidence

Change in Biochemistry - Creatinine and Bilirubin

Time frame:Week 0, week 30

change from baseline, improvement

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

Cardiometabolic biomarkers

14 endpoints
Secondary/registry result

Change in Fasting Blood Lipids: Total Cholesterol

Time frame:Week 0, week 30

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

GroupValue (geometric_mean), ratio95% CI
Semaglutide 1.0 mg0.96
Liraglutide 1.2 mg0.98
Secondary/registry result

Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol

Time frame:Week 0, week 30

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

GroupValue (geometric_mean), ratio95% CI
Semaglutide 1.0 mg0.99
Liraglutide 1.2 mg0.99
Secondary/registry result

Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol

Time frame:Week 0, week 30

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

GroupValue (geometric_mean), ratio95% CI
Semaglutide 1.0 mg1.01
Liraglutide 1.2 mg0.99
Secondary/registry result

Change in Fasting Blood Lipids: Triglycerides

Time frame:Week 0, week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio95% CI
Semaglutide 1.0 mg0.83
Liraglutide 1.2 mg0.91
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

GroupValue (mean), mmHg95% CI
Semaglutide 1.0 mg-4.3
Liraglutide 1.2 mg-3.7
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

GroupValue (mean), mmHg95% CI
Semaglutide 1.0 mg-1.5
Liraglutide 1.2 mg-1.3
Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (geometric_mean), beats/min95% CI
Semaglutide 1.0 mg2.4
Liraglutide 1.2 mg3.9
Secondary/protocol endpoint

Change in Fasting Blood Lipids: Total Cholesterol

Time frame:Week 0, week 30

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol

Time frame:Week 0, week 30

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol

Time frame:Week 0, week 30

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Blood Lipids: 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 Rate

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/registry result

Change in SF-36v2 Short Form Health Survey. Total Summary 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

GroupValue (mean), scores on a scale95% CI
Semaglutide 1.0 mgPhysical functioning1.8
Role-physical1.4
Bodily pain2.2
General health2.7
Social functioning1.7
Role-emotional1.2
Vitality3.0
Mental health1.7
Mental component summary1.7
Physical component summary2.1
Liraglutide 1.2 mgPhysical functioning1.4
Role-physical0.6
Bodily pain1.5
General health1.6
Social functioning0.9
Role-emotional1.0
Vitality1.1
Mental health0.3
Mental component summary0.5
Physical component summary1.4
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 30

change from baseline, improvement

Posted result

GroupValue (mean), scores on a scale95% CI
Semaglutide 1.0 mgQ1. Satisfaction with current treatment0.9
Q2. Hyperglycemia-2.1
Q3. Hypoglycemia0.1
Q4. Flexibility0.7
Q5. Convenience0.7
Q6. Understanding of diabetes0.6
Q7. Recommend treatment to others0.7
Q8. Willingness to continue1.0
Treatment satisfaction summary score4.6
Liraglutide 1.2 mgQ1. Satisfaction with current treatment0.9
Q2. Hyperglycemia-1.6
Q3. Hypoglycemia0.1
Q4. Flexibility0.6
Q5. Convenience0.6
Q6. Understanding of diabetes0.5
Q7. Recommend treatment to others0.7
Q8. Willingness to continue0.9
Treatment satisfaction summary score4.2
Secondary/protocol endpoint

Change in SF-36v2 Short Form Health Survey. Total Summary 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 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 30

change from baseline, improvement

Safety / tolerability / PK

21 endpoints
Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAE)

Time frame:Week 0 to week 35

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 1.0 mg758
Liraglutide 1.2 mg691
Secondary/registry result

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

Time frame:Week 0 to week 35

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupValue (number), Episodes of hypoglycaemia95% CI
Semaglutide 1.0 mg8
Liraglutide 1.2 mg8
Secondary/registry result

Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:Week 0 to week 35

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), Participants95% CI
Semaglutide 1.0 mg5
Liraglutide 1.2 mg7
Secondary/registry result

Change in Haematology - Haemoglobin

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), mmol/L95% CI
Semaglutide 1.0 mg1.0
Liraglutide 1.2 mg1.0
Secondary/registry result

Change in Haematology - Haematocrit

Time frame:Week 0, week 30

percent change from baseline, descriptive

Posted result

GroupValue (geometric_mean), percent change95% CI
Semaglutide 1.0 mg1.5
Liraglutide 1.2 mg1.1
Secondary/registry result

Change in Haematology - Thrombocytes and Leukocytes

Time frame:Week 0, week 30

change from baseline, descriptive

componentsthrombocytes, leukocytes

Posted result

GroupValue (geometric_mean), 10^9 cells/L95% CI
Semaglutide 1.0 mgThrombocytes18.4
Leukocytes0.14
Liraglutide 1.2 mgThrombocytes21.5
Leukocytes0.14
Secondary/registry result

Change in Haematology - Erythrocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), 10^12 cells/L95% CI
Semaglutide 1.0 mg0.14
Liraglutide 1.2 mg0.14
Secondary/registry result

Change in Biochemistry - Calcium, Pottassium and Sodium

Time frame:Week 0, week 30

change from baseline, descriptive

componentscalcium change, potassium change, sodium change

Posted result

GroupValue (geometric_mean), mmol/L95% CI
Semaglutide 1.0 mgCalcium0.07
Pottassium0.3
Sodium1.8
Liraglutide 1.2 mgCalcium0.07
Pottassium0.3
Sodium1.7
Secondary/registry result

Change in Biochemistry - Amylase and Lipase

Time frame:Week 0, week 30

change from baseline, descriptive

componentsamylase change, lipase change

Posted result

GroupValue (geometric_mean), U/L95% CI
Semaglutide 1.0 mgAmylase10.3
Lipase15.8
Liraglutide 1.2 mgAmylase8.4
Lipase14.0
Secondary/registry result

Change in Biochemistry - Creatinine and Bilirubin

Time frame:Week 0, week 30

change from baseline, descriptive

componentsserum creatinine change, bilirubin change

Posted result

GroupValue (geometric_mean), umol/L95% CI
Semaglutide 1.0 mgCreatinine4.1
Bilirubin1.9
Liraglutide 1.2 mgCreatinine3.6
Bilirubin2.0
Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 30

Thyroid event

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), ng/L95% CI
Semaglutide 1.0 mg1.3
Liraglutide 1.2 mg1.1
Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAE)

Time frame:Week 0 to week 35

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:Week 0 to week 35

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:Week 0 to week 35

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

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 and Leukocytes

Time frame:Week 0, week 30

change from baseline, descriptive

componentsthrombocytes, leukocytes

Secondary/protocol endpoint

Change in Haematology - Erythrocytes

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry - Calcium, Pottassium and Sodium

Time frame:Week 0, week 30

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry - Amylase and Lipase

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

Publications (2)

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

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.