Trial Outcomes & Findings for The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease (NCT NCT03829046)
NCT ID: NCT03829046
Last Updated: 2023-03-08
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2023-03-08
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=5 Participants
|
65.9 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking
Current
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking
Former
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Smoking
Never smoker
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Diabetes
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Hypertension
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Cardiovascular Disease (CVD)
Carotid Disease
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cardiovascular Disease (CVD)
Peripheral Artery Disease (PAD)
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Family History
Premature CAD
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Family History
No premature CAD
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Medication Use
Antihypertensive
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Medication Use
Antidiabetics
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Medication Use
High intensity Statins
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Medication Use
Low to moderate intensity Statins
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Medication Use
No Statin (Statin intolerance)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cholesterol Panel
Total Cholesterol
|
189.9 mg/dL
STANDARD_DEVIATION 39.1 • n=5 Participants
|
180.0 mg/dL
STANDARD_DEVIATION 34.7 • n=7 Participants
|
184.7 mg/dL
STANDARD_DEVIATION 36.2 • n=5 Participants
|
|
Cholesterol Panel
LDL-C
|
114.2 mg/dL
STANDARD_DEVIATION 30.4 • n=5 Participants
|
107.7 mg/dL
STANDARD_DEVIATION 32.0 • n=7 Participants
|
110.8 mg/dL
STANDARD_DEVIATION 30.6 • n=5 Participants
|
|
Cholesterol Panel
HDL
|
51.6 mg/dL
STANDARD_DEVIATION 17.8 • n=5 Participants
|
44.9 mg/dL
STANDARD_DEVIATION 11.9 • n=7 Participants
|
48.1 mg/dL
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Cholesterol Panel
Triglycerides
|
129.2 mg/dL
STANDARD_DEVIATION 56.0 • n=5 Participants
|
145.0 mg/dL
STANDARD_DEVIATION 59.2 • n=7 Participants
|
137.5 mg/dL
STANDARD_DEVIATION 56.8 • n=5 Participants
|
|
Albumin
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=7 Participants
|
4.4 g/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Fibrinogen
|
329.9 mg/dL
STANDARD_DEVIATION 80.6 • n=5 Participants
|
317.5 mg/dL
STANDARD_DEVIATION 131.1 • n=7 Participants
|
323.4 mg/dL
STANDARD_DEVIATION 107.5 • n=5 Participants
|
|
HbA1c (glycated hemoglobin)
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.1 • n=7 Participants
|
7.0 percentage of hgb coated with glucose
STANDARD_DEVIATION 1.1 • n=5 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 weeksThe 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 weeksMalondialdehyde levels to measure oxidative stress
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksMyeloperoxidase level to measure inflammation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksInterleukin-6 levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksInterleukin-8 levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksTumor necrosis factor alpha levels to measure cytokines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPlatelet endothelial cell adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksIntercellular adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksVascular cell adhesion molecule levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksAlpha 5/Beta 3 levels to measure vascular endothelial activation
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Evolocumab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
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
|
|---|---|---|
|
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
|
|
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
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
|
|
General disorders
reduced appetite
|
5.3%
1/19 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
Additional Information
Dr. Qinzhong Chen
Icahn School of Medicine at Mount Sinai
Phone: 212-659-8864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place