Trial Outcomes & Findings for The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease (NCT NCT03829046)
NCT ID: NCT03829046
Last Updated: 2026-04-28
Results Overview
Safety as measured by number of adverse events, defined as any untoward medical occurrence in a subject who has been administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
COMPLETED
PHASE4
41 participants
up to 12 weeks
2026-04-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
n=21 Participants
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 9.3 • n=9 Participants
|
65.9 years
STANDARD_DEVIATION 7.7 • n=24 Participants
|
65.7 years
STANDARD_DEVIATION 8.2 • n=23 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
20 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
20 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
17 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
20 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
11 Participants
n=24 Participants
|
19 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Smoking
Current
|
5 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
|
Smoking
Former
|
9 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
18 Participants
n=23 Participants
|
|
Smoking
Never smoker
|
5 Participants
n=9 Participants
|
10 Participants
n=24 Participants
|
15 Participants
n=23 Participants
|
|
Diabetes
|
19 Participants
n=9 Participants
|
21 Participants
n=24 Participants
|
40 Participants
n=23 Participants
|
|
Hypertension
|
17 Participants
n=9 Participants
|
21 Participants
n=24 Participants
|
38 Participants
n=23 Participants
|
|
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
|
11 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
26 Participants
n=23 Participants
|
|
Cardiovascular Disease (CVD)
Carotid Disease
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Cardiovascular Disease (CVD)
Peripheral Artery Disease (PAD)
|
6 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
10 Participants
n=23 Participants
|
|
Family History
Premature CAD
|
4 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Family History
No premature CAD
|
15 Participants
n=9 Participants
|
19 Participants
n=24 Participants
|
34 Participants
n=23 Participants
|
|
Medication Use
Antihypertensive
|
17 Participants
n=9 Participants
|
21 Participants
n=24 Participants
|
38 Participants
n=23 Participants
|
|
Medication Use
Antidiabetics
|
18 Participants
n=9 Participants
|
20 Participants
n=24 Participants
|
38 Participants
n=23 Participants
|
|
Medication Use
High intensity Statins
|
11 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
|
Medication Use
Low to moderate intensity Statins
|
6 Participants
n=9 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=23 Participants
|
|
Medication Use
No Statin (Statin intolerance)
|
2 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Cholesterol Panel
Total Cholesterol
|
189.9 mg/dL
STANDARD_DEVIATION 39.1 • n=9 Participants
|
180.0 mg/dL
STANDARD_DEVIATION 34.7 • n=24 Participants
|
184.7 mg/dL
STANDARD_DEVIATION 36.2 • n=23 Participants
|
|
Cholesterol Panel
LDL-C
|
114.2 mg/dL
STANDARD_DEVIATION 30.4 • n=9 Participants
|
107.7 mg/dL
STANDARD_DEVIATION 32.0 • n=24 Participants
|
110.8 mg/dL
STANDARD_DEVIATION 30.6 • n=23 Participants
|
|
Cholesterol Panel
HDL
|
51.6 mg/dL
STANDARD_DEVIATION 17.8 • n=9 Participants
|
44.9 mg/dL
STANDARD_DEVIATION 11.9 • n=24 Participants
|
48.1 mg/dL
STANDARD_DEVIATION 15.0 • n=23 Participants
|
|
Cholesterol Panel
Triglycerides
|
129.2 mg/dL
STANDARD_DEVIATION 56.0 • n=9 Participants
|
145.0 mg/dL
STANDARD_DEVIATION 59.2 • n=24 Participants
|
137.5 mg/dL
STANDARD_DEVIATION 56.8 • n=23 Participants
|
|
Albumin
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=9 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=24 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=23 Participants
|
|
Fibrinogen
|
329.9 mg/dL
STANDARD_DEVIATION 80.6 • n=9 Participants
|
317.5 mg/dL
STANDARD_DEVIATION 131.1 • n=24 Participants
|
323.4 mg/dL
STANDARD_DEVIATION 107.5 • n=23 Participants
|
|
HbA1c (glycated hemoglobin)
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.2 • n=9 Participants
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.1 • n=24 Participants
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.1 • n=23 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksSafety as measured by number of adverse events, defined as any untoward medical occurrence in a subject who has been administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
n=21 Participants
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
|---|---|---|
|
Number of Adverse Events
|
13 events
|
13 events
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: No results reported because no patients reported chest discomfort, so Seattle Questionnaire was not administered.
The Seattle Angina Questionnaire is a quality-of-life measure for patients with coronary artery disease. The SAQ is a self-report instrument with 19 items that yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. There is no summary score generated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Malondialdehyde levels to measure oxidative stress
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Myeloperoxidase level to measure inflammation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Interleukin-6 levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Interleukin-8 levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Tumor necrosis factor alpha levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Platelet endothelial cell adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Intercellular adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Vascular cell adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The specimens were not collected was due to blood volume requirements that would exceed the maximum allowed per phlebotomy per IRB approval. The blood viscosity specimens required more volume than anticipated.
Alpha 5/Beta 3 levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Evolocumab
Serious adverse events
| Measure |
Placebo
n=19 participants at risk
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
n=21 participants at risk
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
|---|---|---|
|
Infections and infestations
Acute Osteomyelitis
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Nervous system disorders
Seizure Type activity
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Nervous system disorders
Ataxia
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Vascular disorders
Critical limb ischemia
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Exertional Dyspnea
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Cardiac disorders
Hospital Admission- Unsuccessful PTA
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Metabolism and nutrition disorders
Cervical Stenosis of Spine
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Placebo SC QM x 12 weeks of treatment
|
Evolocumab
n=21 participants at risk
Evolocumab SC 420mg/dL QM x 12 weeks of treatment
|
|---|---|---|
|
General disorders
weird taste in mouth right after injection
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
pain under breast on and off
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
reduced appetite
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
General disorders
patient felt disoriented and confused after first injection
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Psychiatric disorders
worsening memory
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
General disorders
drowsy right after injections
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
General disorders
stomach cramps
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like Symptoms
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin itching
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
Headache
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/19 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Cardiac disorders
Chest Pain
|
10.5%
2/19 • 12 weeks
|
9.5%
2/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
pinch at injection site when consumes greasy food
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
Additional Information
Dr. Robert S. Rosenson
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place