Trial Outcomes & Findings for Liraglutide and Peripheral Artery Disease (NCT NCT04881110)
NCT ID: NCT04881110
Last Updated: 2025-03-03
Results Overview
Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Liraglutide Group
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=27 Participants
|
65.0 years
n=28 Participants
|
65 years
n=55 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=27 Participants
|
6 Participants
n=28 Participants
|
12 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=27 Participants
|
22 Participants
n=28 Participants
|
43 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Duration of diabetes
|
11.0 years
n=27 Participants
|
10.0 years
n=28 Participants
|
10 years
n=55 Participants
|
|
TcPO2
|
40.0 mmHg
STANDARD_DEVIATION 5.9 • n=27 Participants
|
40.5 mmHg
STANDARD_DEVIATION 5.7 • n=28 Participants
|
40.3 mmHg
STANDARD_DEVIATION 5.8 • n=55 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTranscutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Peripheral Transcutaneous Oxygen Pressure
|
54.2 mmHg
Standard Deviation 5.9
|
43.4 mmHg
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 6 monthsHbA1c values after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
HbA1c Glucose Control
|
6.7 percentage of HbA1c
Standard Deviation 0.7
|
6.8 percentage of HbA1c
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsfasting glucose differences between groups
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Glucose Control
|
118.5 mg/dL
Interval 91.0 to 132.5
|
117 mg/dL
Interval 98.0 to 122.0
|
SECONDARY outcome
Timeframe: 6 monthsWeight value at 6 months minus value at baseline
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Weight Change
|
78.5 Kg
Standard Deviation 14.4
|
80.7 Kg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 6 monthsBMI value at 6 months minus value at baseline
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
BMI Change
|
28.7 Kg/m2
Standard Deviation 4
|
27.7 Kg/m2
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 6 monthsWaist circumference value at 6 months minus value at baseline
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Waist Circumference Change
|
108.9 cm
Standard Deviation 10.3
|
104.1 cm
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 6 monthssystolic blood pressure value at 6 months minus value at baseline
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Systolic Blood Pressure Change
|
130 mmHg
Interval 120.0 to 130.0
|
130 mmHg
Interval 125.0 to 140.0
|
SECONDARY outcome
Timeframe: 6 monthstotal cholesterol after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Lipid Profile
|
142.3 mg/dL
Standard Deviation 40.6
|
158.8 mg/dL
Standard Deviation 55.1
|
SECONDARY outcome
Timeframe: 6 monthsCRP value at 6 months minus value at baseline
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
C-reactive Protein (CRP) Change
|
0.5 mg/dL
Standard Deviation 0.5
|
0.8 mg/dL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthscreatinine levels after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Renal Function
|
1 mg/dL
Interval 0.8 to 1.2
|
0.8 mg/dL
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: 6 monthsestimated glomerular filtration rate after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Estimated Glomerular Filtration Rate
|
71 mL/min/1.73 m^2
Standard Deviation 18.4
|
74.7 mL/min/1.73 m^2
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 6 monthsvascular endothelial growth factor (VEGF) after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Angiogenesis
|
124 pg/mL
Interval 77.5 to 188.0
|
68.4 pg/mL
Interval 52.2 to 80.8
|
SECONDARY outcome
Timeframe: 6 monthsABI value after 6 months minus value at baseline ABI evaluation was obtained dividing the leg systolic pressure by the arm systolic pressure, both detected through a doppler probe and a sphygmomanometer. Normal ABI ranges from 1.0 to 1.4. ABI values above 1.4 suggest a noncompressible calcified vessel. ABI value below 0.9 is considered diagnostic of PAD.
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Ankle-brachial Index (ABI) Change
|
0.9 ratio
Interval 0.9 to 1.0
|
1 ratio
Interval 0.9 to 1.1
|
SECONDARY outcome
Timeframe: 6 monthsSexual hormone binding protein after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Sexual Hormonal Profile
|
45 nmol/L
Interval 34.1 to 51.7
|
49.5 nmol/L
Interval 44.5 to 66.2
|
SECONDARY outcome
Timeframe: 6 monthsErectile function (IIEF-5) score at 6 months Male patients will perform a self-assessment test (IIEF-5) of their erectile function and overall satisfaction with sexual life, referring to the previous 6 months. Erectile dysfunction (ED) will be classified based on the total questionnaire score. The highest score available is 25, the lowest is 0. Any score ranging from 25 and 22 refers to the absence of ED. Any score ≤ 21 will indicate the presence of ED \[mild (score 21-17), mild-moderate (score 16 -12), moderate (score 11-8) and severe (score 7-1)\]. The IIEF-5 questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).
Outcome measures
| Measure |
Liraglutide Group
n=21 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=22 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Male Sexual Function
|
12.4 score on a scale
Standard Deviation 5.7
|
12.5 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 6 monthsFemale sexual function (FSFI) after 6 months Female sexual function will be studied through the FSFI questionnaire which assesses sexual activity over the past 4 weeks and includes 19 questions. The questionnaire will investigate six distinct domains (sexual desire, arousal, lubrication, orgasm, satisfaction and pain), and provide a total score indicative of global sexual function. Points are assigned for each answer (from 1 to 5 for 1-2 questions, from 0 to 5 for 3-19): the sum of the scores for each domain is multiplied by a domain factor (desire 0.6, arousal 0.3, lubrication 0.3 orgasm 0.4, satisfaction 0.4, pain 0.4). The six domain scores are added up, and the total score may vary from 2.0 to 36.0 points. A total FSFI score \< 26.55 will be used to classify the presence of female sexual dysfunction. The FSFI questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).
Outcome measures
| Measure |
Liraglutide Group
n=6 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=6 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
Female Sexual Function
|
20.4 score on a scale
Standard Deviation 1.4
|
21.2 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 months6-minutes walking distance after 6 months
Outcome measures
| Measure |
Liraglutide Group
n=27 Participants
Patients in this arm will receive liraglutide, according to the current clinical practice.
Liraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
|
Control Group
n=28 Participants
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Control: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
|
|---|---|---|
|
6-minute Walking Test
|
364 meters
Standard Deviation 13.7
|
340 meters
Standard Deviation 11.5
|
Adverse Events
Liraglutide Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Katherine Esposito, Head of the Division of Endocrinology and Metabolic Diseases
University of Campania Luigi Vanvitelli
Phone: +390815665031
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place