Liraglutide improves peripheral perfusion and markers of angiogenesis and inflammation in people with type 2 diabetes and peripheral artery disease: An 18-month follow-up of a randomized clinical trial.

Caruso P, Maiorino MI, Longo M, Maio A, Scappaticcio L, Di Martino N, Carbone C, Barrasso M, Caputo M, Gicchino M, Bellastella G, Giugliano D, Esposito K

Diabetes, obesity & metabolism25 Apr 2025Cited by 12 (Europe PMC)

PMID40276845PMCIDPMC12146450DOI10.1111/dom.16419PepBankPUB-40276845

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Summary

AimsIn a six-month randomized clinical trial, improved peripheral perfusion has been shown with liraglutide, associated with favourable vascular effects in people with type 2 diabetes and peripheral artery disease (PAD). We aimed to evaluate the durability of these benefits and to elucidate some mechanisms underlying liraglutide's effect over an 18-month follow-up.MethodsSTARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD. We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters. TcPO₂ was assessed with transcutaneous oximetry. Circulating levels of angiogenic progenitor cells and serum inflammation markers were evaluated by flow cytometry and enzyme-linked immunosorbent assay, respectively.ResultsCompared with the control group, significant differences favouring the liraglutide group were observed at 18 months for TcPO₂ [estimated treated difference (95% CI), 10.9 mmHg (7.6 to 14.1 mmHg), p < 0.001]. At 18 months of follow-up, participants in the liraglutide group, as compared with those in the control group, had a significant reduction in urine albumin to creatinine ratio (estimated difference, -103.9 mg/g Cr, 95%CI, -170.8 to -37.1, p = 0.003), C-reactive protein (-0.5 mg/dL, 95%CI, -0.8 to -0.2, p = 0.002), as well as interleukin-6 (-32.6 pg/mL, 95%CI, -54.6 to -10.5, p = 0.004). Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺. Liraglutide was also associated with a higher increase in vascular endothelial growth factor A at 18 months (70.1 pg/mL, 95%CI, 44.7 to 95.4, p < 0.001).ConclusionsIn people with type 2 diabetes and PAD, liraglutide increased peripheral perfusion, with amelioration of markers of angiogenesis and inflammation over an 18-month follow-up.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased transcutaneous oxygen pressure versus control at 18 months (estimated difference 10.9 mmHg,95% CI 7.6 to 14.1;P<0.001); continuous 18-month drug exposure was unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased peripheral oxygen pressure more than control.
Peptide
Liraglutide
Outcome
IncreaseTranscutaneous oxygen pressure
Study
n: not reported in source
Comparator
Control group
Analysis
Primary
Outcome group
Vascular function · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Measurements
Estimated difference
10.9 mmHg
Transcutaneous oxygen pressure at18-month follow-up versus tailored risk-factor control
95% CI
7.6 to 14.1 mmHg
estimated difference
P-value
< 0.001
Transcutaneous oxygen pressure versus control
Source sentences
Summary
Compared with the control group, significant differences favouring the liraglutide group were observed at 18 months for TcPO₂ [estimated treated difference (95% CI), 10.9 mmHg (7.6 to 14.1 mmHg), p < 0.001].
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684501
02HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide reduced urine albumin-to-creatinine ratio versus control at 18 months (estimated difference -103.9 mg/g Cr,95% CI -170.8 to -37.1;P=0.003); continuous 18-month drug exposure was unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide lowered urine albumin-to-creatinine ratio more than control.
Peptide
Liraglutide
Outcome
DecreaseUrine albumin-to-creatinine ratio
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Measurements
Estimated difference
−103.9 mg/g Cr
Urine albumin-to-creatinine ratio at18-month follow-up versus tailored risk-factor control
95% CI
−170.8 to −37.1 mg/g Cr
estimated difference
P-value
0.003
Urine albumin-to-creatinine ratio versus control
Source sentences
Summary
urine albumin to creatinine ratio (estimated difference, -103.9 mg/g Cr, 95%CI, -170.8 to -37.1, p = 0.003)
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684502
03HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide reduced C-reactive protein versus control at 18 months (estimated difference -0.5 mg/dL,95% CI -0.8 to -0.2;P=0.002); continuous 18-month drug exposure was unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide lowered C-reactive protein more than control.
Peptide
Liraglutide
Outcome
DecreaseC-reactive protein
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Measurements
Estimated difference
−0.5 mg/dL
C-reactive protein at18-month follow-up versus tailored risk-factor control
95% CI
−0.8 to −0.2 mg/dL
estimated difference
P-value
0.002
C-reactive protein versus control
Source sentences
Summary
C-reactive protein (-0.5 mg/dL, 95%CI, -0.8 to -0.2, p = 0.002)
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684503
04HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide reduced interleukin-6 versus control at 18 months (estimated difference -32.6 pg/mL,95% CI -54.6 to -10.5;P=0.004); continuous 18-month drug exposure was unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide lowered interleukin-6 more than control.
Peptide
Liraglutide
Outcome
DecreaseInterleukin-6
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Measurements
Estimated difference
−32.6 pg/mL
Interleukin-6 at18-month follow-up versus tailored risk-factor control
95% CI
−54.6 to −10.5 pg/mL
estimated difference
P-value
0.004
Interleukin-6 versus control
Source sentences
Summary
interleukin-6 (-32.6 pg/mL, 95%CI, -54.6 to -10.5, p = 0.004).
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684504
05HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased CD34-positive circulating progenitor cells versus control at 6 and 18 months; visit times were6 and18 months, but continuous drug-exposure duration and analyzed N were unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased CD34-positive progenitor cells more than control.
Peptide
Liraglutide
Outcome
IncreaseCD34-positive circulating progenitor cells
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺.
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684505
06HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased CD133-positive circulating progenitor cells versus control at 6 and 18 months; visit times were6 and18 months, but continuous drug-exposure duration and analyzed N were unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased CD133-positive progenitor cells more than control.
Peptide
Liraglutide
Outcome
IncreaseCD133-positive circulating progenitor cells
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺.
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684506
07HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased KDR-positive circulating progenitor cells versus control at 6 and 18 months; visit times were6 and18 months, but continuous drug-exposure duration and analyzed N were unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased KDR-positive progenitor cells more than control.
Peptide
Liraglutide
Outcome
IncreaseKDR-positive circulating progenitor cells
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺.
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684507
08HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased CD34-positive/KDR-positive circulating progenitor cells versus control at 6 and 18 months; visit times were6 and18 months, but continuous drug-exposure duration and analyzed N were unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased CD34-positive/KDR-positive progenitor cells more than control.
Peptide
Liraglutide
Outcome
IncreaseCD34-positive/KDR-positive circulating progenitor cells
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺.
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684508
09HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased CD34-positive/CD133-positive/KDR-positive circulating progenitor cells versus control at 6 and 18 months; visit times were6 and18 months, but continuous drug-exposure duration and analyzed N were unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased CD34-positive/CD133-positive/KDR-positive progenitor cells more than control.
Peptide
Liraglutide
Outcome
IncreaseCD34-positive/CD133-positive/KDR-positive circulating progenitor cells
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Compared with the control group, participants in the liraglutide group showed significantly higher concentrations of circulating progenitor cells and endothelial progenitor cells at both 6 and 18 months, for CD34⁺, CD133⁺, KDR⁺, CD34⁺/KDR⁺ and CD34⁺/CD133⁺/KDR⁺.
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684509
10HumanRandomized controlled trialEfficacy outcome
In people with type 2 diabetes and peripheral artery disease, liraglutide increased vascular endothelial growth factor A versus control at 18 months (estimated difference 70.1 pg/mL,95% CI 44.7 to 95.4;P<0.001); continuous 18-month drug exposure was unstated.
In plain wordsIn people with T2D and peripheral artery disease, liraglutide increased vascular endothelial growth factor A more than control.
Peptide
Liraglutide
Outcome
IncreaseVascular endothelial growth factor A
Study
n: not reported in source
Comparator
Control group
Analysis
Secondary
Outcome group
Angiogenesis · Cardiovascular
Studied dose
up to 1.8 mg/dayAs given in this study (human).
Measurements
Estimated difference
70.1 pg/mL
Vascular endothelial growth factor A at18-month follow-up versus tailored risk-factor control
95% CI
44.7 to 95.4 pg/mL
estimated difference
P-value
< 0.001
Vascular endothelial growth factor A versus control
Source sentences
Summary
Liraglutide was also associated with a higher increase in vascular endothelial growth factor A at 18 months (70.1 pg/mL, 95%CI, 44.7 to 95.4, p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
STARDUST was a randomized clinical trial which compared liraglutide up to 1.8 mg/day with tailored therapeutic prescriptions to manage cardiovascular risk factors in 55 participants with type 2 diabetes and PAD.
Summary · context
We report data of people who have reached the 18-month follow-up for the primary outcome (transcutaneous oxygen pressure, TcPO₂) and also for additional secondary outcomes (markers of inflammation, angiogenesis and kidney function), as well as glycemic and metabolic parameters.
Show in the study text Report a problemFND-4027684510

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Version history

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Version 2Current
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

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Liraglutide improves peripheral perfusion and markers of angiogenesis and inflammation in people with type 2 diabetes and peripheral artery disease: An 18-month follow-up of a randomized clinical trial.

Summary

Results from this study10

Version history

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Keywords