← Trials/Trial dossier/NCT03191396
SUSTAIN 10
CompletedPhase 3Results postedResearch 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
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
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
Weight & body composition
14 endpointsChange in Body Weight (kg)
Time frame:Week 0, week 30
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -5.8 | — |
| Liraglutide 1.2 mg | -2.0 | — |
Change in Body Mass Index (BMI)
Time frame:Week 0, week 30
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), kg/sqm | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -2.0 | — |
| Liraglutide 1.2 mg | -0.7 | — |
Change in Waist Circumference
Time frame:Week 0, week 30
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -5.2 | — |
| Liraglutide 1.2 mg | -2.4 | — |
Change in Body Weight (%)
Time frame:Week 0, week 30
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage of body weight | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -6.1 | — |
| Liraglutide 1.2 mg | -2.0 | — |
Subjects Who Achieve Weight Loss Above or Equal to 3%
Time frame:After 30 weeks of treatment
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 72.7 | — |
| Liraglutide 1.2 mg | 33.9 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 55.9 | — |
| Liraglutide 1.2 mg | 17.7 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 19.1 | — |
| Liraglutide 1.2 mg | 4.4 | — |
Change in Body Weight (kg)
Time frame:Week 0, week 30
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Mass Index (BMI)
Time frame:Week 0, week 30
BMI, change
change from baseline, improvement
Change in Waist Circumference
Time frame:Week 0, week 30
Waist circumference, change
change from baseline, improvement
Change in Body Weight (%)
Time frame:Week 0, week 30
Body weight, % change
percent change from baseline, improvement
Subjects Who Achieve Weight Loss Above or Equal to 3%
Time frame:After 30 weeks of treatment
threshold achievement, improvement
Subjects Who Achieve Weight Loss Above or Equal to 5%
Time frame:After 30 weeks of treatment
≥5% weight-loss responders
threshold achievement, improvement
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 endpointsChange in HbA1c
Time frame:Week 0, week 30
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of glycosylated haemoglobin | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -1.7 | — |
| Liraglutide 1.2 mg | -1.1 | — |
Change in HbA1c
Time frame:Week 0, week 30
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (FPG)
Time frame:Week 0, week 30
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -2.65 | — |
| Liraglutide 1.2 mg | -1.46 | — |
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
Time frame:Week 0, week 30
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -3.0 | — |
| Liraglutide 1.2 mg | -2.1 | — |
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
Time frame:Week 0, week 30
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -1.0 | — |
| Liraglutide 1.2 mg | -0.4 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 80.4 | — |
| Liraglutide 1.2 mg | 45.9 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 58.5 | — |
| Liraglutide 1.2 mg | 24.8 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 75.6 | — |
| Liraglutide 1.2 mg | 36.8 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 82.8 | — |
| Liraglutide 1.2 mg | 48.3 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 62.4 | — |
| Liraglutide 1.2 mg | 20.9 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 49.6 | — |
| Liraglutide 1.2 mg | 11.9 | — |
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
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 17.1 | — |
| Liraglutide 1.2 mg | 3.6 | — |
Change in Fasting Plasma Glucose (FPG)
Time frame:Week 0, week 30
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
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
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
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
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
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
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
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
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
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 endpointsChange 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
| Group | Value (geometric_mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgAlkaline phosphatase | 5.5 | — |
| Alanine Aminotransferase | 5.3 | — |
| Aspartate Aminotransferase | 3.5 | — |
| Liraglutide 1.2 mgAlkaline phosphatase | 6.4 | — |
| Alanine Aminotransferase | 5.0 | — |
| Aspartate Aminotransferase | 3.1 | — |
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 endpointsChange in Biochemistry - Albumin
Time frame:Week 0, week 30
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), g/dL | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 0.2 | — |
| Liraglutide 1.2 mg | 0.2 | — |
Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
Time frame:Week 0, week 30
eGFR, change
change from baseline, improvement
LOINC 98979-8
Posted result
| Group | Value (geometric_mean), mL/min/1.73m2 | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 4.0 | — |
| Liraglutide 1.2 mg | 4.1 | — |
Change in Biochemistry - Creatinine and Bilirubin
Time frame:Week 0, week 30
change from baseline, improvement
Change in Biochemistry - Albumin
Time frame:Week 0, week 30
change from baseline, improvement
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 endpointsChange in Fasting Blood Lipids: Total Cholesterol
Time frame:Week 0, week 30
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), ratio | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 0.96 | — |
| Liraglutide 1.2 mg | 0.98 | — |
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
| Group | Value (geometric_mean), ratio | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 0.99 | — |
| Liraglutide 1.2 mg | 0.99 | — |
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
| Group | Value (geometric_mean), ratio | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 1.01 | — |
| Liraglutide 1.2 mg | 0.99 | — |
Change in Fasting Blood Lipids: Triglycerides
Time frame:Week 0, week 30
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 0.83 | — |
| Liraglutide 1.2 mg | 0.91 | — |
Change in Systolic Blood Pressure
Time frame:Week 0, week 30
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -4.3 | — |
| Liraglutide 1.2 mg | -3.7 | — |
Change in Diastolic Blood Pressure
Time frame:Week 0, week 30
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -1.5 | — |
| Liraglutide 1.2 mg | -1.3 | — |
Change in Pulse Rate
Time frame:Week 0, week 30
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), beats/min | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 2.4 | — |
| Liraglutide 1.2 mg | 3.9 | — |
Change in Fasting Blood Lipids: Total Cholesterol
Time frame:Week 0, week 30
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
Time frame:Week 0, week 30
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
Time frame:Week 0, week 30
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in Fasting Blood Lipids: Triglycerides
Time frame:Week 0, week 30
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Systolic Blood Pressure
Time frame:Week 0, week 30
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Diastolic Blood Pressure
Time frame:Week 0, week 30
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Pulse Rate
Time frame:Week 0, week 30
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
4 endpointsChange 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
| Group | Value (mean), scores on a scale | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgPhysical functioning | 1.8 | — |
| Role-physical | 1.4 | — |
| Bodily pain | 2.2 | — |
| General health | 2.7 | — |
| Social functioning | 1.7 | — |
| Role-emotional | 1.2 | — |
| Vitality | 3.0 | — |
| Mental health | 1.7 | — |
| Mental component summary | 1.7 | — |
| Physical component summary | 2.1 | — |
| Liraglutide 1.2 mgPhysical functioning | 1.4 | — |
| Role-physical | 0.6 | — |
| Bodily pain | 1.5 | — |
| General health | 1.6 | — |
| Social functioning | 0.9 | — |
| Role-emotional | 1.0 | — |
| Vitality | 1.1 | — |
| Mental health | 0.3 | — |
| Mental component summary | 0.5 | — |
| Physical component summary | 1.4 | — |
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
| Group | Value (mean), scores on a scale | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgQ1. Satisfaction with current treatment | 0.9 | — |
| Q2. Hyperglycemia | -2.1 | — |
| Q3. Hypoglycemia | 0.1 | — |
| Q4. Flexibility | 0.7 | — |
| Q5. Convenience | 0.7 | — |
| Q6. Understanding of diabetes | 0.6 | — |
| Q7. Recommend treatment to others | 0.7 | — |
| Q8. Willingness to continue | 1.0 | — |
| Treatment satisfaction summary score | 4.6 | — |
| Liraglutide 1.2 mgQ1. Satisfaction with current treatment | 0.9 | — |
| Q2. Hyperglycemia | -1.6 | — |
| Q3. Hypoglycemia | 0.1 | — |
| Q4. Flexibility | 0.6 | — |
| Q5. Convenience | 0.6 | — |
| Q6. Understanding of diabetes | 0.5 | — |
| Q7. Recommend treatment to others | 0.7 | — |
| Q8. Willingness to continue | 0.9 | — |
| Treatment satisfaction summary score | 4.2 | — |
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
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 endpointsNumber of Treatment-emergent Adverse Events (TEAE)
Time frame:Week 0 to week 35
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 758 | — |
| Liraglutide 1.2 mg | 691 | — |
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
| Group | Value (number), Episodes of hypoglycaemia | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 8 | — |
| Liraglutide 1.2 mg | 8 | — |
Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
Time frame:Week 0 to week 35
Severe hypoglycemia
event count, event
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 5 | — |
| Liraglutide 1.2 mg | 7 | — |
Change in Haematology - Haemoglobin
Time frame:Week 0, week 30
change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 1.0 | — |
| Liraglutide 1.2 mg | 1.0 | — |
Change in Haematology - Haematocrit
Time frame:Week 0, week 30
percent change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), percent change | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 1.5 | — |
| Liraglutide 1.2 mg | 1.1 | — |
Change in Haematology - Thrombocytes and Leukocytes
Time frame:Week 0, week 30
change from baseline, descriptive
componentsthrombocytes, leukocytes
Posted result
| Group | Value (geometric_mean), 10^9 cells/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgThrombocytes | 18.4 | — |
| Leukocytes | 0.14 | — |
| Liraglutide 1.2 mgThrombocytes | 21.5 | — |
| Leukocytes | 0.14 | — |
Change in Haematology - Erythrocytes
Time frame:Week 0, week 30
change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), 10^12 cells/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 0.14 | — |
| Liraglutide 1.2 mg | 0.14 | — |
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
| Group | Value (geometric_mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgCalcium | 0.07 | — |
| Pottassium | 0.3 | — |
| Sodium | 1.8 | — |
| Liraglutide 1.2 mgCalcium | 0.07 | — |
| Pottassium | 0.3 | — |
| Sodium | 1.7 | — |
Change in Biochemistry - Amylase and Lipase
Time frame:Week 0, week 30
change from baseline, descriptive
componentsamylase change, lipase change
Posted result
| Group | Value (geometric_mean), U/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgAmylase | 10.3 | — |
| Lipase | 15.8 | — |
| Liraglutide 1.2 mgAmylase | 8.4 | — |
| Lipase | 14.0 | — |
Change in Biochemistry - Creatinine and Bilirubin
Time frame:Week 0, week 30
change from baseline, descriptive
componentsserum creatinine change, bilirubin change
Posted result
| Group | Value (geometric_mean), umol/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgCreatinine | 4.1 | — |
| Bilirubin | 1.9 | — |
| Liraglutide 1.2 mgCreatinine | 3.6 | — |
| Bilirubin | 2.0 | — |
Change in Calcitonin
Time frame:Week 0, week 30
Thyroid event
change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), ng/L | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 1.3 | — |
| Liraglutide 1.2 mg | 1.1 | — |
Number of Treatment-emergent Adverse Events (TEAE)
Time frame:Week 0 to week 35
Treatment-emergent AEs (any)
event count, event
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
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
Change in Haematology - Haemoglobin
Time frame:Week 0, week 30
change from baseline, descriptive
Change in Haematology - Haematocrit
Time frame:Week 0, week 30
change from baseline, descriptive
Change in Haematology - Thrombocytes and Leukocytes
Time frame:Week 0, week 30
change from baseline, descriptive
componentsthrombocytes, leukocytes
Change in Haematology - Erythrocytes
Time frame:Week 0, week 30
change from baseline, descriptive
Change in Biochemistry - Calcium, Pottassium and Sodium
Time frame:Week 0, week 30
change from baseline, descriptive
Change in Biochemistry - Amylase and Lipase
Time frame:Week 0, week 30
change from baseline, descriptive
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
- Diabetes therapy : research, treatment and education of diabetes and related disorders2020 May (month)PMID32193837doi:10.1007/s13300-020-00796-zvia clinicaltrials gov reference derived + pubmed nct search
- Diabetes & metabolism2020 Apr (month)PMID31539622doi:10.1016/j.diabet.2019.101117via CT.gov reference
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.