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A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial
Lead sponsor
Assets
Liraglutide / Semaglutide
Listed sites
77
Recruiting sites
—
Enrollment
415
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (70)
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
2 endpointsHbA1c
Time frame:After 12 weeks of treatment.
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage (%) of HbA1c | 95% CI |
|---|---|---|
| Placebo | -0.5 | — |
| Semaglutide 0.1 mg | -0.6 | — |
| Semaglutide 0.2 mg | -0.9 | — |
| Semaglutide 0.4 mg | -1.0 | — |
| Semaglutide 0.8 mg | -1.4 | — |
| Semaglutide 0.8 mg (With Titration) | -1.4 | — |
| Semaglutide 1.6 mg (With Titration) | -1.5 | — |
| Liraglutide 1.2 mg | -1.1 | — |
| Liraglutide 1.8 mg | -1.3 | — |
HbA1c
Time frame:After 12 weeks of treatment.
HbA1c, change
change from baseline, improvement
LOINC 4548-4
MASH / liver
4 endpointsChange From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
Time frame:Week 0, week 12.
AST, change
change from baseline, improvement
LOINC 1920-8
Posted result
| Group | Value (mean), U/L | 95% CI |
|---|---|---|
| Placebo | -1.09 | — |
| Semaglutide 0.1 mg | 1.23 | — |
| Semaglutide 0.2 mg | 0.24 | — |
| Semaglutide 0.4 mg | -1.81 | — |
| Semaglutide 0.8 mg | -0.37 | — |
| Semaglutide 0.8 mg (With Titration) | -2.60 | — |
| Semaglutide 1.6 mg (With Titration) | -4.07 | — |
| Liraglutide 1.2 mg | -0.16 | — |
| Liraglutide 1.8 mg | -2.13 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
Time frame:Week 0, week 12.
ALT, change
change from baseline, improvement
LOINC 1742-6
Posted result
| Group | Value (mean), U/L | 95% CI |
|---|---|---|
| Placebo | -2.41 | — |
| Semaglutide 0.1 mg | 0.83 | — |
| Semaglutide 0.2 mg | 0.68 | — |
| Semaglutide 0.4 mg | -4.21 | — |
| Semaglutide 0.8 mg | -2.13 | — |
| Semaglutide 0.8 mg (With Titration) | -6.19 | — |
| Semaglutide 1.6 mg (With Titration) | -6.55 | — |
| Liraglutide 1.2 mg | -0.88 | — |
| Liraglutide 1.8 mg | -1.83 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
Time frame:Week 0, week 12.
AST, change
change from baseline, improvement
LOINC 1920-8
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
Time frame:Week 0, week 12.
ALT, change
change from baseline, improvement
LOINC 1742-6
Cardiometabolic biomarkers
6 endpointsChange From Baseline in Vital Signs (Pulse)
Time frame:Week 0, week 12
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats/minute | 95% CI |
|---|---|---|
| Placebo | 0.5 | — |
| Semaglutide 0.1 mg | -0.0 | — |
| Semaglutide 0.2 mg | 0.5 | — |
| Semaglutide 0.4 mg | 1.5 | — |
| Semaglutide 0.8 mg | 1.5 | — |
| Semaglutide 0.8 mg (With Titration) | 2.9 | — |
| Semaglutide 1.6 mg (With Titration) | 3.9 | — |
| Liraglutide 1.2 mg | 4.4 | — |
| Liraglutide 1.8 mg | 2.1 | — |
Change From Baseline in Vital Signs (Blood Pressure; SBP)
Time frame:Week 0, week 12
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Placebo | -3.2 | — |
| Semaglutide 0.1 mg | 3.3 | — |
| Semaglutide 0.2 mg | -2.5 | — |
| Semaglutide 0.4 mg | -3.6 | — |
| Semaglutide 0.8 mg | -6.7 | — |
| Semaglutide 0.8 mg (With Titration) | -7.7 | — |
| Semaglutide 1.6 mg (With Titration) | -5.9 | — |
| Liraglutide 1.2 mg | -2.9 | — |
| Liraglutide 1.8 mg | -5.4 | — |
Change From Baseline in Vital Signs (Blood Pressure; DBP)
Time frame:Week 0, week 12
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Placebo | -2.3 | — |
| Semaglutide 0.1 mg | 1.5 | — |
| Semaglutide 0.2 mg | -0.4 | — |
| Semaglutide 0.4 mg | -1.5 | — |
| Semaglutide 0.8 mg | -1.5 | — |
| Semaglutide 0.8 mg (With Titration) | -2.3 | — |
| Semaglutide 1.6 mg (With Titration) | -3.0 | — |
| Liraglutide 1.2 mg | -2.1 | — |
| Liraglutide 1.8 mg | -0.0 | — |
Change From Baseline in Vital Signs (Pulse)
Time frame:Week 0, week 12
Heart rate, change
change from baseline, improvement
Change From Baseline in Vital Signs (Blood Pressure; SBP)
Time frame:Week 0, week 12
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change From Baseline in Vital Signs (Blood Pressure; DBP)
Time frame:Week 0, week 12
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Safety / tolerability / PK
58 endpointsPercentage of Subjects With an Adverse Events
Time frame:After 12 weeks of treatment.
Treatment-emergent AEs (any)
threshold achievement, event
Posted result
| Group | Value (number), Percentage (%) of subjects | 95% CI |
|---|---|---|
| Placebo | 43.5 | — |
| Semaglutide 0.1 mg | 59.6 | — |
| Semaglutide 0.2 mg | 55.8 | — |
| Semaglutide 0.4 mg | 72.9 | — |
| Semaglutide 0.8 mg | 85.7 | — |
| Semaglutide 0.8 mg (With Titration) | 72.1 | — |
| Semaglutide 1.6 mg (With Titration) | 93.6 | — |
| Liraglutide 1.2 mg | 55.6 | — |
| Liraglutide 1.8 mg | 62.0 | — |
Percentage of Subjects With Hypoglycaemic Episode
Time frame:After 12 weeks of treatment
Documented hypoglycemia
threshold achievement, event
Posted result
| Group | Value (number), Percentage (%) of subjects | 95% CI |
|---|---|---|
| PlaceboMajor | 0 | — |
| Minor | 0 | — |
| Symptoms only | 2.2 | — |
| Semaglutide 0.1 mgMajor | 0 | — |
| Minor | 4.3 | — |
| Symptoms only | 2.1 | — |
| Semaglutide 0.2 mgMajor | 0 | — |
| Minor | 0 | — |
| Symptoms only | 2.3 | — |
| Semaglutide 0.4 mgMajor | 0 | — |
| Minor | 4.2 | — |
| Symptoms only | 0 | — |
| Semaglutide 0.8 mgMajor | 0 | — |
| Minor | 0 | — |
| Symptoms only | 0 | — |
| Semaglutide 0.8 mg (With Titration)Major | 0 | — |
| Minor | 2.3 | — |
| Symptoms only | 0 | — |
| Semaglutide 1.6 mg (With Titration)Major | 0 | — |
| Minor | 0 | — |
| Symptoms only | 6.4 | — |
| Liraglutide 1.2 mgMajor | 0 | — |
| Minor | 4.4 | — |
| Symptoms only | 8.9 | — |
| Liraglutide 1.8 mgMajor | 0 | — |
| Minor | 2.0 | — |
| Symptoms only | 2.0 | — |
Change From Baseline in ECG
Time frame:Week 0, week 12.
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek -2: Normal | 42 | — |
| Week -2: Abnormal, NCS | 4 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 39 | — |
| Week 12: Abnormal, NCS | 6 | — |
| Week 12: Abnormal, CS | 0 | — |
| Week 12: ECG not done (ND) | 1 | — |
| Semaglutide 0.1 mgWeek -2: Normal | 33 | — |
| Week -2: Abnormal, NCS | 14 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 32 | — |
| Week 12: Abnormal, NCS | 14 | — |
| Week 12: Abnormal, CS | 0 | — |
| Week 12: ECG not done (ND) | 1 | — |
| Semaglutide 0.2 mgWeek -2: Normal | 37 | — |
| Week -2: Abnormal, NCS | 6 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 34 | — |
| Week 12: Abnormal, NCS | 3 | — |
| Week 12: Abnormal, CS | 1 | — |
| Week 12: ECG not done (ND) | 5 | — |
| Semaglutide 0.4 mgWeek -2: Normal | 34 | — |
| Week -2: Abnormal, NCS | 12 | — |
| Week -2: Abnormal, CS | 2 | — |
| Week 12: Normal | 36 | — |
| Week 12: Abnormal, NCS | 7 | — |
| Week 12: Abnormal, CS | 2 | — |
| Week 12: ECG not done (ND) | 1 | — |
| Semaglutide 0.8 mgWeek -2: Normal | 31 | — |
| Week -2: Abnormal, NCS | 10 | — |
| Week -2: Abnormal, CS | 1 | — |
| Week 12: Normal | 29 | — |
| Week 12: Abnormal, NCS | 7 | — |
| Week 12: Abnormal, CS | 1 | — |
| Week 12: ECG not done (ND) | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week -2: Normal | 28 | — |
| Week -2: Abnormal, NCS | 15 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 33 | — |
| Week 12: Abnormal, NCS | 9 | — |
| Week 12: Abnormal, CS | 0 | — |
| Week 12: ECG not done (ND) | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week -2: Normal | 37 | — |
| Week -2: Abnormal, NCS | 8 | — |
| Week -2: Abnormal, CS | 2 | — |
| Week 12: Normal | 36 | — |
| Week 12: Abnormal, NCS | 5 | — |
| Week 12: Abnormal, CS | 3 | — |
| Week 12: ECG not done (ND) | 2 | — |
| Liraglutide 1.2 mgWeek -2: Normal | 39 | — |
| Week -2: Abnormal, NCS | 6 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 37 | — |
| Week 12: Abnormal, NCS | 6 | — |
| Week 12: Abnormal, CS | 0 | — |
| Week 12: ECG not done (ND) | 2 | — |
| Liraglutide 1.8 mgWeek -2: Normal | 41 | — |
| Week -2: Abnormal, NCS | 9 | — |
| Week -2: Abnormal, CS | 0 | — |
| Week 12: Normal | 42 | — |
| Week 12: Abnormal, NCS | 5 | — |
| Week 12: Abnormal, CS | 0 | — |
| Week 12: ECG not done (ND) | 2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | -0.0 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.0 | — |
| Semaglutide 0.4 mg | 0.0 | — |
| Semaglutide 0.8 mg | -0.0 | — |
| Semaglutide 0.8 mg (With Titration) | -0.0 | — |
| Semaglutide 1.6 mg (With Titration) | -0.0 | — |
| Liraglutide 1.2 mg | 0.0 | — |
| Liraglutide 1.8 mg | 0.0 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | -0.0 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.0 | — |
| Semaglutide 0.4 mg | 0.0 | — |
| Semaglutide 0.8 mg | -0.0 | — |
| Semaglutide 0.8 mg (With Titration) | 0.0 | — |
| Semaglutide 1.6 mg (With Titration) | 0.1 | — |
| Liraglutide 1.2 mg | 0.0 | — |
| Liraglutide 1.8 mg | -0.0 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Litre/litre (L/L) | 95% CI |
|---|---|---|
| Placebo | -0.01 | — |
| Semaglutide 0.1 mg | -0.01 | — |
| Semaglutide 0.2 mg | -0.01 | — |
| Semaglutide 0.4 mg | 0.00 | — |
| Semaglutide 0.8 mg | -0.01 | — |
| Semaglutide 0.8 mg (With Titration) | -0.00 | — |
| Semaglutide 1.6 mg (With Titration) | -0.00 | — |
| Liraglutide 1.2 mg | 0.00 | — |
| Liraglutide 1.8 mg | -0.01 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Gram/litre (g/L) | 95% CI |
|---|---|---|
| Placebo | 0.1 | — |
| Semaglutide 0.1 mg | -0.4 | — |
| Semaglutide 0.2 mg | -1.2 | — |
| Semaglutide 0.4 mg | 2.8 | — |
| Semaglutide 0.8 mg | -0.3 | — |
| Semaglutide 0.8 mg (With Titration) | 1.5 | — |
| Semaglutide 1.6 mg (With Titration) | 1.0 | — |
| Liraglutide 1.2 mg | 2.1 | — |
| Liraglutide 1.8 mg | 1.1 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | -0.1 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.1 | — |
| Semaglutide 0.4 mg | 0.2 | — |
| Semaglutide 0.8 mg | -0.0 | — |
| Semaglutide 0.8 mg (With Titration) | -0.1 | — |
| Semaglutide 1.6 mg (With Titration) | 0.1 | — |
| Liraglutide 1.2 mg | 0.0 | — |
| Liraglutide 1.8 mg | -0.1 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | 0.1 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.0 | — |
| Semaglutide 0.4 mg | 0.1 | — |
| Semaglutide 0.8 mg | 0.1 | — |
| Semaglutide 0.8 mg (With Titration) | 0.0 | — |
| Semaglutide 1.6 mg (With Titration) | 0.1 | — |
| Liraglutide 1.2 mg | 0.1 | — |
| Liraglutide 1.8 mg | 0.1 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | 0.1 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.1 | — |
| Semaglutide 0.4 mg | 0.3 | — |
| Semaglutide 0.8 mg | -0.1 | — |
| Semaglutide 0.8 mg (With Titration) | 0.5 | — |
| Semaglutide 1.6 mg (With Titration) | 0.5 | — |
| Liraglutide 1.2 mg | 0.3 | — |
| Liraglutide 1.8 mg | 0.3 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | 9.0 | — |
| Semaglutide 0.1 mg | 16.1 | — |
| Semaglutide 0.2 mg | 10.8 | — |
| Semaglutide 0.4 mg | 10.7 | — |
| Semaglutide 0.8 mg | 5.4 | — |
| Semaglutide 0.8 mg (With Titration) | 5.5 | — |
| Semaglutide 1.6 mg (With Titration) | 15.9 | — |
| Liraglutide 1.2 mg | 10.1 | — |
| Liraglutide 1.8 mg | 16.7 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Trillion cells/litre (10^12/L) | 95% CI |
|---|---|---|
| Placebo | -0.04 | — |
| Semaglutide 0.1 mg | -0.06 | — |
| Semaglutide 0.2 mg | -0.03 | — |
| Semaglutide 0.4 mg | 0.08 | — |
| Semaglutide 0.8 mg | -0.05 | — |
| Semaglutide 0.8 mg (With Titration) | 0.03 | — |
| Semaglutide 1.6 mg (With Titration) | 0.04 | — |
| Liraglutide 1.2 mg | 0.04 | — |
| Liraglutide 1.8 mg | 0.02 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Posted result
| Group | Value (mean), Billion cells/litre (10^9/L) | 95% CI |
|---|---|---|
| Placebo | 0.05 | — |
| Semaglutide 0.1 mg | 0.04 | — |
| Semaglutide 0.2 mg | -0.16 | — |
| Semaglutide 0.4 mg | 0.59 | — |
| Semaglutide 0.8 mg | 0.14 | — |
| Semaglutide 0.8 mg (With Titration) | 0.41 | — |
| Semaglutide 1.6 mg (With Titration) | 0.70 | — |
| Liraglutide 1.2 mg | 0.40 | — |
| Liraglutide 1.8 mg | 0.26 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), g/L | 95% CI |
|---|---|---|
| Placebo | 0.402 | — |
| Semaglutide 0.1 mg | 0.130 | — |
| Semaglutide 0.2 mg | -0.091 | — |
| Semaglutide 0.4 mg | -0.177 | — |
| Semaglutide 0.8 mg | 0.303 | — |
| Semaglutide 0.8 mg (With Titration) | 0.607 | — |
| Semaglutide 1.6 mg (With Titration) | 0.271 | — |
| Liraglutide 1.2 mg | 0.916 | — |
| Liraglutide 1.8 mg | 0.846 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), U/L | 95% CI |
|---|---|---|
| Placebo | -0.52 | — |
| Semaglutide 0.1 mg | -1.66 | — |
| Semaglutide 0.2 mg | -2.37 | — |
| Semaglutide 0.4 mg | -2.35 | — |
| Semaglutide 0.8 mg | -1.39 | — |
| Semaglutide 0.8 mg (With Titration) | -2.81 | — |
| Semaglutide 1.6 mg (With Titration) | -3.98 | — |
| Liraglutide 1.2 mg | -1.89 | — |
| Liraglutide 1.8 mg | -4.25 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), umol/L | 95% CI |
|---|---|---|
| Placebo | 0.7 | — |
| Semaglutide 0.1 mg | -0.4 | — |
| Semaglutide 0.2 mg | 0.6 | — |
| Semaglutide 0.4 mg | 0.8 | — |
| Semaglutide 0.8 mg | 0.7 | — |
| Semaglutide 0.8 mg (With Titration) | 1.3 | — |
| Semaglutide 1.6 mg (With Titration) | 0.4 | — |
| Liraglutide 1.2 mg | -0.5 | — |
| Liraglutide 1.8 mg | 0.2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Placebo | 0.0 | — |
| Semaglutide 0.1 mg | -0.0 | — |
| Semaglutide 0.2 mg | -0.0 | — |
| Semaglutide 0.4 mg | -0.0 | — |
| Semaglutide 0.8 mg | 0.0 | — |
| Semaglutide 0.8 mg (With Titration) | 0.0 | — |
| Semaglutide 1.6 mg (With Titration) | -0.0 | — |
| Liraglutide 1.2 mg | -0.0 | — |
| Liraglutide 1.8 mg | 0.0 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Placebo | 0.00 | — |
| Semaglutide 0.1 mg | -0.01 | — |
| Semaglutide 0.2 mg | -0.04 | — |
| Semaglutide 0.4 mg | -0.01 | — |
| Semaglutide 0.8 mg | -0.01 | — |
| Semaglutide 0.8 mg (With Titration) | 0.01 | — |
| Semaglutide 1.6 mg (With Titration) | -0.02 | — |
| Liraglutide 1.2 mg | -0.02 | — |
| Liraglutide 1.8 mg | -0.01 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), umol/L | 95% CI |
|---|---|---|
| Placebo | -1.02 | — |
| Semaglutide 0.1 mg | 0.936 | — |
| Semaglutide 0.2 mg | -0.349 | — |
| Semaglutide 0.4 mg | -2.31 | — |
| Semaglutide 0.8 mg | -0.658 | — |
| Semaglutide 0.8 mg (With Titration) | -1.67 | — |
| Semaglutide 1.6 mg (With Titration) | 2.089 | — |
| Liraglutide 1.2 mg | 0.841 | — |
| Liraglutide 1.8 mg | -0.917 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Placebo | 0.07 | — |
| Semaglutide 0.1 mg | 0.08 | — |
| Semaglutide 0.2 mg | 0.06 | — |
| Semaglutide 0.4 mg | -0.02 | — |
| Semaglutide 0.8 mg | 0.04 | — |
| Semaglutide 0.8 mg (With Titration) | -0.02 | — |
| Semaglutide 1.6 mg (With Titration) | -0.07 | — |
| Liraglutide 1.2 mg | 0.10 | — |
| Liraglutide 1.8 mg | -0.12 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Placebo | 0.1 | — |
| Semaglutide 0.1 mg | 0.0 | — |
| Semaglutide 0.2 mg | -0.1 | — |
| Semaglutide 0.4 mg | -0.1 | — |
| Semaglutide 0.8 mg | 0.4 | — |
| Semaglutide 0.8 mg (With Titration) | 0.2 | — |
| Semaglutide 1.6 mg (With Titration) | 0.5 | — |
| Liraglutide 1.2 mg | 0.7 | — |
| Liraglutide 1.8 mg | 0.6 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
Time frame:Week 0, week 12.
change from baseline, descriptive
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Placebo | -0.1 | — |
| Semaglutide 0.1 mg | 0.1 | — |
| Semaglutide 0.2 mg | -0.1 | — |
| Semaglutide 0.4 mg | -0.4 | — |
| Semaglutide 0.8 mg | -0.3 | — |
| Semaglutide 0.8 mg (With Titration) | -0.5 | — |
| Semaglutide 1.6 mg (With Titration) | -0.5 | — |
| Liraglutide 1.2 mg | -0.1 | — |
| Liraglutide 1.8 mg | -0.4 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Time frame:Week 0, week 12
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek 0: Negative | 31 | — |
| Week 0: Positive | 13 | — |
| Week 0: >=55 mmol/L | 1 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 34 | — |
| Week 12: Positive | 8 | — |
| Week 12: >=55 mmol/L | 2 | — |
| Week 12: Missing | 0 | — |
| Semaglutide 0.1 mgWeek 0: Negative | 26 | — |
| Week 0: Positive | 18 | — |
| Week 0: >=55 mmol/L | 3 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 28 | — |
| Week 12: Positive | 15 | — |
| Week 12: >=55 mmol/L | 2 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.2 mgWeek 0: Negative | 23 | — |
| Week 0: Positive | 15 | — |
| Week 0: >=55 mmol/L | 5 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 28 | — |
| Week 12: Positive | 8 | — |
| Week 12: >=55 mmol/L | 3 | — |
| Week 12: Missing | 2 | — |
| Semaglutide 0.4 mgWeek 0: Negative | 35 | — |
| Week 0: Positive | 11 | — |
| Week 0: >=55 mmol/L | 2 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 35 | — |
| Week 12: Positive | 8 | — |
| Week 12: >=55 mmol/L | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.8 mgWeek 0: Negative | 23 | — |
| Week 0: Positive | 15 | — |
| Week 0: >=55 mmol/L | 3 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 30 | — |
| Week 12: Positive | 2 | — |
| Week 12: >=55 mmol/L | 2 | — |
| Week 12: Missing | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week 0: Negative | 28 | — |
| Week 0: Positive | 10 | — |
| Week 0: >=55 mmol/L | 3 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 39 | — |
| Week 12: Positive | 1 | — |
| Week 12: >=55 mmol/L | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week 0: Negative | 32 | — |
| Week 0: Positive | 12 | — |
| Week 0: >=55 mmol/L | 2 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 39 | — |
| Week 12: Positive | 3 | — |
| Week 12: >=55 mmol/L | 0 | — |
| Week 12: Missing | 1 | — |
| Liraglutide 1.2 mgWeek 0: Negative | 30 | — |
| Week 0: Positive | 10 | — |
| Week 0: >=55 mmol/L | 3 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 35 | — |
| Week 12: Positive | 7 | — |
| Week 12: >=55 mmol/L | 1 | — |
| Week 12: Missing | 0 | — |
| Liraglutide 1.8 mgWeek 0: Negative | 22 | — |
| Week 0: Positive | 20 | — |
| Week 0: >=55 mmol/L | 5 | — |
| Week 0: Missing | 3 | — |
| Week 12: Negative | 39 | — |
| Week 12: Positive | 6 | — |
| Week 12: >=55 mmol/L | 0 | — |
| Week 12: Missing | 2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Time frame:Week 0, week 12
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek 0: Negative | 45 | — |
| Week 0: Trace | 0 | — |
| Week 0: Small | 0 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 42 | — |
| Week 12: Trace | 0 | — |
| Week 12: Small | 1 | — |
| Week 12: Large | 1 | — |
| Week 12: Missing | 0 | — |
| Semaglutide 0.1 mgWeek 0: Negative | 45 | — |
| Week 0: Trace | 2 | — |
| Week 0: Small | 0 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 45 | — |
| Week 12: Trace | 0 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.2 mgWeek 0: Negative | 41 | — |
| Week 0: Trace | 1 | — |
| Week 0: Small | 1 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 38 | — |
| Week 12: Trace | 1 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 2 | — |
| Semaglutide 0.4 mgWeek 0: Negative | 45 | — |
| Week 0: Trace | 1 | — |
| Week 0: Small | 0 | — |
| Week 0: Moderate | 2 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 42 | — |
| Week 12: Trace | 2 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.8 mgWeek 0: Negative | 38 | — |
| Week 0: Trace | 2 | — |
| Week 0: Small | 0 | — |
| Week 0: Moderate | 1 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 30 | — |
| Week 12: Trace | 1 | — |
| Week 12: Small | 2 | — |
| Week 12: Large | 1 | — |
| Week 12: Missing | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week 0: Negative | 39 | — |
| Week 0: Trace | 1 | — |
| Week 0: Small | 1 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 38 | — |
| Week 12: Trace | 1 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week 0: Negative | 43 | — |
| Week 0: Trace | 2 | — |
| Week 0: Small | 1 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 39 | — |
| Week 12: Trace | 2 | — |
| Week 12: Small | 1 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 1 | — |
| Liraglutide 1.2 mgWeek 0: Negative | 43 | — |
| Week 0: Trace | 0 | — |
| Week 0: Small | 0 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 43 | — |
| Week 12: Trace | 0 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 0 | — |
| Liraglutide 1.8 mgWeek 0: Negative | 45 | — |
| Week 0: Trace | 1 | — |
| Week 0: Small | 1 | — |
| Week 0: Moderate | 0 | — |
| Week 0: Missing | 3 | — |
| Week 12: Negative | 44 | — |
| Week 12: Trace | 1 | — |
| Week 12: Small | 0 | — |
| Week 12: Large | 0 | — |
| Week 12: Missing | 2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Time frame:Week 0, week 12
descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek 0: Negative | 45 | — |
| Week 0: Positive | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 43 | — |
| Week 12: Positive | 1 | — |
| Week 12: Missing | 0 | — |
| Semaglutide 0.1 mgWeek 0: Negative | 47 | — |
| Week 0: Positive | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 44 | — |
| Week 12: Positive | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.2 mgWeek 0: Negative | 39 | — |
| Week 0: Positive | 4 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 35 | — |
| Week 12: Positive | 4 | — |
| Week 12: Missing | 2 | — |
| Semaglutide 0.4 mgWeek 0: Negative | 46 | — |
| Week 0: Positive | 2 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 44 | — |
| Week 12: Positive | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.8 mgWeek 0: Negative | 41 | — |
| Week 0: Positive | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 34 | — |
| Week 12: Positive | 0 | — |
| Week 12: Missing | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week 0: Negative | 41 | — |
| Week 0: Positive | 0 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 40 | — |
| Week 12: Positive | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week 0: Negative | 45 | — |
| Week 0: Positive | 1 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 38 | — |
| Week 12: Positive | 4 | — |
| Week 12: Missing | 1 | — |
| Liraglutide 1.2 mgWeek 0: Negative | 42 | — |
| Week 0: Positive | 1 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 41 | — |
| Week 12: Positive | 2 | — |
| Week 12: Missing | 0 | — |
| Liraglutide 1.8 mgWeek 0: Negative | 46 | — |
| Week 0: Positive | 1 | — |
| Week 0: Missing | 3 | — |
| Week 12: Negative | 43 | — |
| Week 12: Positive | 2 | — |
| Week 12: Missing | 2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Time frame:Week 0, week 12
descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek 0: 6.0 | 16 | — |
| Week 0: 6.5 | 13 | — |
| Week 0: 7.0 | 11 | — |
| Week 0: 7.5 | 4 | — |
| Week 0: 8.0 | 0 | — |
| Week 0: >=8.5 | 1 | — |
| Week 0: Missing | 1 | — |
| Week 12: 6.0 | 11 | — |
| Week 12: 6.5 | 15 | — |
| Week 12: 7.0 | 15 | — |
| Week 12: 7.5 | 3 | — |
| Week 12: 8.0 | 0 | — |
| Week 12: >=8.5 | 0 | — |
| Week 12: Missing | 0 | — |
| Semaglutide 0.1 mgWeek 0: 6.0 | 13 | — |
| Week 0: 6.5 | 18 | — |
| Week 0: 7.0 | 12 | — |
| Week 0: 7.5 | 3 | — |
| Week 0: 8.0 | 0 | — |
| Week 0: >=8.5 | 1 | — |
| Week 0: Missing | 0 | — |
| Week 12: 6.0 | 14 | — |
| Week 12: 6.5 | 14 | — |
| Week 12: 7.0 | 13 | — |
| Week 12: 7.5 | 2 | — |
| Week 12: 8.0 | 1 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.2 mgWeek 0: 6.0 | 19 | — |
| Week 0: 6.5 | 15 | — |
| Week 0: 7.0 | 8 | — |
| Week 0: 7.5 | 0 | — |
| Week 0: 8.0 | 1 | — |
| Week 0: >=8.5 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: 6.0 | 19 | — |
| Week 12: 6.5 | 9 | — |
| Week 12: 7.0 | 6 | — |
| Week 12: 7.5 | 4 | — |
| Week 12: 8.0 | 1 | — |
| Week 12: >=8.5 | 0 | — |
| Week 12: Missing | 2 | — |
| Semaglutide 0.4 mgWeek 0: 6.0 | 11 | — |
| Week 0: 6.5 | 21 | — |
| Week 0: 7.0 | 10 | — |
| Week 0: 7.5 | 5 | — |
| Week 0: 8.0 | 1 | — |
| Week 0: >=8.5 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: 6.0 | 9 | — |
| Week 12: 6.5 | 14 | — |
| Week 12: 7.0 | 11 | — |
| Week 12: 7.5 | 7 | — |
| Week 12: 8.0 | 2 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.8 mgWeek 0: 6.0 | 10 | — |
| Week 0: 6.5 | 13 | — |
| Week 0: 7.0 | 12 | — |
| Week 0: 7.5 | 5 | — |
| Week 0: 8.0 | 0 | — |
| Week 0: >=8.5 | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: 6.0 | 10 | — |
| Week 12: 6.5 | 7 | — |
| Week 12: 7.0 | 11 | — |
| Week 12: 7.5 | 3 | — |
| Week 12: 8.0 | 2 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week 0: 6.0 | 11 | — |
| Week 0: 6.5 | 13 | — |
| Week 0: 7.0 | 8 | — |
| Week 0: 7.5 | 8 | — |
| Week 0: 8.0 | 0 | — |
| Week 0: >=8.5 | 1 | — |
| Week 0: Missing | 2 | — |
| Week 12: 6.0 | 8 | — |
| Week 12: 6.5 | 10 | — |
| Week 12: 7.0 | 15 | — |
| Week 12: 7.5 | 5 | — |
| Week 12: 8.0 | 1 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week 0: 6.0 | 14 | — |
| Week 0: 6.5 | 10 | — |
| Week 0: 7.0 | 12 | — |
| Week 0: 7.5 | 7 | — |
| Week 0: 8.0 | 3 | — |
| Week 0: >=8.5 | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: 6.0 | 13 | — |
| Week 12: 6.5 | 11 | — |
| Week 12: 7.0 | 10 | — |
| Week 12: 7.5 | 5 | — |
| Week 12: 8.0 | 1 | — |
| Week 12: >=8.5 | 2 | — |
| Week 12: Missing | 1 | — |
| Liraglutide 1.2 mgWeek 0: 6.0 | 8 | — |
| Week 0: 6.5 | 16 | — |
| Week 0: 7.0 | 14 | — |
| Week 0: 7.5 | 3 | — |
| Week 0: 8.0 | 2 | — |
| Week 0: >=8.5 | 0 | — |
| Week 0: Missing | 2 | — |
| Week 12: 6.0 | 9 | — |
| Week 12: 6.5 | 13 | — |
| Week 12: 7.0 | 16 | — |
| Week 12: 7.5 | 4 | — |
| Week 12: 8.0 | 0 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 0 | — |
| Liraglutide 1.8 mgWeek 0: 6.0 | 12 | — |
| Week 0: 6.5 | 11 | — |
| Week 0: 7.0 | 19 | — |
| Week 0: 7.5 | 2 | — |
| Week 0: 8.0 | 1 | — |
| Week 0: >=8.5 | 2 | — |
| Week 0: Missing | 3 | — |
| Week 12: 6.0 | 10 | — |
| Week 12: 6.5 | 14 | — |
| Week 12: 7.0 | 15 | — |
| Week 12: 7.5 | 3 | — |
| Week 12: 8.0 | 2 | — |
| Week 12: >=8.5 | 1 | — |
| Week 12: Missing | 2 | — |
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Time frame:Week 0, week 12
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboWeek 0: Negative | 45 | — |
| Week 0: 0.3 | 0 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 40 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 4 | — |
| Week 12: 1.0 | 0 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 0 | — |
| Semaglutide 0.1 mgWeek 0: Negative | 47 | — |
| Week 0: 0.3 | 0 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 43 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 2 | — |
| Week 12: 1.0 | 0 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.2 mgWeek 0: Negative | 41 | — |
| Week 0: 0.3 | 2 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 35 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 3 | — |
| Week 12: 1.0 | 1 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 2 | — |
| Semaglutide 0.4 mgWeek 0: Negative | 44 | — |
| Week 0: 0.3 | 4 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 41 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 3 | — |
| Week 12: 1.0 | 0 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 0.8 mgWeek 0: Negative | 39 | — |
| Week 0: 0.3 | 2 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 0 | — |
| Week 12: Negative | 31 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 3 | — |
| Week 12: 1.0 | 0 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 3 | — |
| Semaglutide 0.8 mg (With Titration)Week 0: Negative | 40 | — |
| Week 0: 0.3 | 0 | — |
| Week 0: 1.0 | 1 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 36 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 3 | — |
| Week 12: 1.0 | 1 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 1 | — |
| Semaglutide 1.6 mg (With Titration)Week 0: Negative | 46 | — |
| Week 0: 0.3 | 0 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 1 | — |
| Week 12: Negative | 39 | — |
| Week 12: Trace | 1 | — |
| Week 12: 0.3 | 2 | — |
| Week 12: 1.0 | 0 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 1 | — |
| Liraglutide 1.2 mgWeek 0: Negative | 41 | — |
| Week 0: 0.3 | 2 | — |
| Week 0: 1.0 | 0 | — |
| Week 0: Missing | 2 | — |
| Week 12: Negative | 40 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 1 | — |
| Week 12: 1.0 | 1 | — |
| Week 12: >=3.0 | 1 | — |
| Week 12: Missing | 0 | — |
| Liraglutide 1.8 mgWeek 0: Negative | 45 | — |
| Week 0: 0.3 | 1 | — |
| Week 0: 1.0 | 1 | — |
| Week 0: Missing | 3 | — |
| Week 12: Negative | 41 | — |
| Week 12: Trace | 0 | — |
| Week 12: 0.3 | 3 | — |
| Week 12: 1.0 | 1 | — |
| Week 12: >=3.0 | 0 | — |
| Week 12: Missing | 2 | — |
Change From Baseline in Calcitonin
Time frame:Week 0, week 12.
Thyroid event
change from baseline, descriptive
Posted result
| Group | Value (mean), ng/L | 95% CI |
|---|---|---|
| Placebo | 0.43 | — |
| Semaglutide 0.1 mg | 0.48 | — |
| Semaglutide 0.2 mg | -0.48 | — |
| Semaglutide 0.4 mg | 0.62 | — |
| Semaglutide 0.8 mg | 0.45 | — |
| Semaglutide 0.8 mg (With Titration) | 0.87 | — |
| Semaglutide 1.6 mg (With Titration) | 0.76 | — |
| Liraglutide 1.2 mg | 0.55 | — |
| Liraglutide 1.8 mg | 0.01 | — |
Percentage of Subjects Developing Anti-semaglutide Antibodies
Time frame:After 12 weeks of treatment
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (number), Percentage (%) of participants | 95% CI |
|---|---|---|
| Placebo | 0 | — |
| Semaglutide 0.1 mg | 0 | — |
| Semaglutide 0.2 mg | 0 | — |
| Semaglutide 0.4 mg | 0 | — |
| Semaglutide 0.8 mg | 0 | — |
| Semaglutide 0.8 mg (With Titration) | 0 | — |
| Semaglutide 1.6 mg (With Titration) | 3 | — |
Percentage of Subjects With an Adverse Events
Time frame:After 12 weeks of treatment.
Treatment-emergent AEs (any)
threshold achievement, event
Percentage of Subjects With Hypoglycaemic Episode
Time frame:After 12 weeks of treatment
Documented hypoglycemia
threshold achievement, event
Change From Baseline in ECG
Time frame:Week 0, week 12.
categorical status, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
Time frame:Week 0, week 12
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
Time frame:Week 0, week 12.
change from baseline, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Time frame:Week 0, week 12
descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Time frame:Week 0, week 12
descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Time frame:Week 0, week 12
categorical status, descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Time frame:Week 0, week 12
descriptive
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Time frame:Week 0, week 12
categorical status, descriptive
Change From Baseline in Calcitonin
Time frame:Week 0, week 12.
Thyroid event
change from baseline, event
Percentage of Subjects Developing Anti-semaglutide Antibodies
Time frame:After 12 weeks of treatment
Immunogenicity (ADA)
threshold achievement, event
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
- Diabetes care2016 Feb (month)PMID26358288doi:10.2337/dc15-0165via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.