Trial Outcomes & Findings for The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus (NCT NCT00620282)
NCT ID: NCT00620282
Last Updated: 2017-03-08
Results Overview
Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
49 participants
Primary outcome timeframe
week 0, week 12
Results posted on
2017-03-08
Participant Flow
The trial was conducted at one site in the United States of America (USA).
Participant milestones
| Measure |
Lira 1.8
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Lira 1.8
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Arterial line unable to be placed
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Duration of Diabetes
|
5.3 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
6.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Previous Anti-diabetic Treatment
Diet/Exercise
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Previous Anti-diabetic Treatment
Metformin
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
32.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Body Weight
|
95.09 kg
STANDARD_DEVIATION 13.12 • n=5 Participants
|
90.63 kg
STANDARD_DEVIATION 13.47 • n=7 Participants
|
91.99 kg
STANDARD_DEVIATION 13.97 • n=5 Participants
|
92.56 kg
STANDARD_DEVIATION 13.38 • n=4 Participants
|
|
Glycosylated Haemoglobin A1c (HbA1c)
|
7.2 percentage of total haemoglobin
STANDARD_DEVIATION 0.5 • n=5 Participants
|
7.0 percentage of total haemoglobin
STANDARD_DEVIATION 0.5 • n=7 Participants
|
7.3 percentage of total haemoglobin
STANDARD_DEVIATION 0.5 • n=5 Participants
|
7.2 percentage of total haemoglobin
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
Fasting Plasma Glucose (FPG)
|
160.8 mg/dL
STANDARD_DEVIATION 31.2 • n=5 Participants
|
145.2 mg/dL
STANDARD_DEVIATION 20.1 • n=7 Participants
|
163.3 mg/dL
STANDARD_DEVIATION 33.3 • n=5 Participants
|
156.6 mg/dL
STANDARD_DEVIATION 29.4 • n=4 Participants
|
|
Total Cholesterol (TC)
|
170.2 mg/dL
STANDARD_DEVIATION 34.4 • n=5 Participants
|
157.5 mg/dL
STANDARD_DEVIATION 32.0 • n=7 Participants
|
160.2 mg/dL
STANDARD_DEVIATION 24.1 • n=5 Participants
|
162.6 mg/dL
STANDARD_DEVIATION 30.2 • n=4 Participants
|
|
Low density lipoprotein (LDL-C)
|
102.8 mg/dL
STANDARD_DEVIATION 31.3 • n=5 Participants
|
92.5 mg/dL
STANDARD_DEVIATION 23.5 • n=7 Participants
|
94.1 mg/dL
STANDARD_DEVIATION 18.4 • n=5 Participants
|
96.4 mg/dL
STANDARD_DEVIATION 24.8 • n=4 Participants
|
|
High density lipoprotein (HDL-C)
|
39.6 mg/dL
STANDARD_DEVIATION 10.0 • n=5 Participants
|
39.2 mg/dL
STANDARD_DEVIATION 7.5 • n=7 Participants
|
43.5 mg/dL
STANDARD_DEVIATION 10.3 • n=5 Participants
|
40.8 mg/dL
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Triglycerides (TG)
|
165.8 mg/dL
STANDARD_DEVIATION 72.9 • n=5 Participants
|
145.9 mg/dL
STANDARD_DEVIATION 57.5 • n=7 Participants
|
141.4 mg/dL
STANDARD_DEVIATION 67.4 • n=5 Participants
|
150.8 mg/dL
STANDARD_DEVIATION 65.7 • n=4 Participants
|
|
Tumor necrosis factor-alpha (TNF-alpha)
|
2.1 pg/mL
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.4 pg/mL
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.4 pg/mL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.6 pg/mL
STANDARD_DEVIATION 1.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
|
4.244 mL/100 mL/min
Standard Error 2.551
|
-3.187 mL/100 mL/min
Standard Error 2.758
|
2.164 mL/100 mL/min
Standard Error 2.568
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
|
3.455 mL/100 mL/min
Standard Error 2.681
|
-1.044 mL/100 mL/min
Standard Error 2.893
|
2.746 mL/100 mL/min
Standard Error 2.67
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Percentage point change in HbA1c
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin A1c)
|
-0.629 percentage of total haemoglobin
Standard Error 0.109
|
-0.094 percentage of total haemoglobin
Standard Error 0.121
|
-0.552 percentage of total haemoglobin
Standard Error 0.112
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in FPG
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-41.672 mg/dL
Standard Error 3.643
|
-6.067 mg/dL
Standard Error 4.079
|
-32.019 mg/dL
Standard Error 3.708
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.
Outcome measures
| Measure |
Lira 1.8
n=13 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=10 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=14 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
|
-32.175 mg/dL
Standard Error 9.104
|
-20.304 mg/dL
Standard Error 10.619
|
-35.99 mg/dL
Standard Error 8.673
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Change in Body Weight
|
-1.821 kg
Standard Error 0.455
|
-0.293 kg
Standard Error 0.486
|
1.038 kg
Standard Error 0.441
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in TC
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Fasting Lipid Profile - Change in Total Cholesterol (TC)
|
2.006 mg/dL
Standard Error 5.274
|
4.243 mg/dL
Standard Error 5.597
|
0.094 mg/dL
Standard Error 5.239
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in LDL-C
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Fasting Lipid Profile - Change in LDL-C
|
1.243 mg/dL
Standard Error 4.294
|
-2.459 mg/dL
Standard Error 4.551
|
-1.529 mg/dL
Standard Error 4.275
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in HDL-C
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Fasting Lipid Profile - Change in HDL-C
|
0.393 mg/dL
Standard Error 1.053
|
0.562 mg/dL
Standard Error 1.133
|
1.116 mg/dL
Standard Error 1.074
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in TG
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=14 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=16 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Fasting Lipid Profile - Change in Triglycerides (TG)
|
-8.163 mg/dL
Standard Error 13.471
|
28.546 mg/dL
Standard Error 14.282
|
-4.377 mg/dL
Standard Error 13.399
|
SECONDARY outcome
Timeframe: week 0, week 12Population: The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.
Change in TNF-alpha
Outcome measures
| Measure |
Lira 1.8
n=12 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=10 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=12 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Biomarkers of Cardiovascular Risk - Change in TNF-alpha
|
-0.024 pg/mL
Standard Error 0.232
|
0.397 pg/mL
Standard Error 0.25
|
-0.0050 pg/mL
Standard Error 0.231
|
SECONDARY outcome
Timeframe: week 0, week 12Population: Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
Week 0
|
1 participants
|
0 participants
|
1 participants
|
|
Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
Week 12
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: week 0, week 12Population: Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
Week 0
|
1 participants
|
3 participants
|
5 participants
|
|
Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
Week 12
|
1 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: weeks 0-12Population: Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Outcome measures
| Measure |
Lira 1.8
n=16 Participants
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 Participants
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 Participants
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Number of Hypoglycaemic Episodes
Major
|
0 episodes
|
0 episodes
|
0 episodes
|
|
Number of Hypoglycaemic Episodes
Minor
|
1 episodes
|
0 episodes
|
10 episodes
|
|
Number of Hypoglycaemic Episodes
Symptoms Only
|
3 episodes
|
0 episodes
|
4 episodes
|
Adverse Events
Lira 1.8
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Glimepiride
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lira 1.8
n=16 participants at risk
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 participants at risk
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 participants at risk
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
Other adverse events
| Measure |
Lira 1.8
n=16 participants at risk
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Placebo
n=16 participants at risk
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
|
Glimepiride
n=17 participants at risk
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Gastrointestinal disorders
Parotid Duct Obstruction
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
General disorders
Catheter Site Haematoma
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
General disorders
Chest Pain
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
General disorders
Fatigue
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Otitis media
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Head Injury
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle Disorder
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
5.9%
1/17 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
6.2%
1/16 • Number of events 1 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
0.00%
0/17 • The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right to not release data until specified milestones (e.g. when clinical trial report is available), including right to not release interim results because such action can invalidate results of the entire trial. At trial end, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER