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Trial · Interventional

CompletedPhase 4Registry data

Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects

Short name Rebuild

NCTNCT02621489 (opens ClinicalTrials.gov in a new tab)Other idBY2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
38 participants (actual)
Sponsor
Karolinska Institutet · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Sweden

Start
Dec 2015
Primary completion
Aug 2022
Completion
Oct 2022
First posted
3 Dec 2015 (estimated)
Last update posted
20 Apr 2023
Conditions
Atherosclerosis · Diabetes · Restenosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. Ph 4

    Rebuild

    NCT02621489

    Dec 2015 to Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of the study is to use Exenatide long-acting release (LAR) \[Bydureon\] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.

Interventions

  • BydureonDrug
  • Humulin kwickpenDrug
  • MetforminDrug

Arms2

  • Experimental

    Bydureon 2 mg Once Weekly

    Patients randomised to Bydureon will be treated with Metformin 1g BID, and only receive 10U of Humulin kwickpen QD at bedtime, with no more up-titration of insulin during the study.

  • Active comparator

    Humulin kwickpen

    Patients randomised to the comparator group will be treated with Meformin 1g BID and Humulin kwickpen to reach a fP-glucose level of 6 mmol/l. For that reason patients will be instructed to increase the bedtime Insulin dose of 2-4U every third day until this goal is reached.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT).

    Time frame · 12 weeks

Secondary outcomes(15)

  1. Fractional Flow Reserve (FFR)

    Time frame · 12 weeks

    Registry description

    FFR is a unitless index calculated as the ratio between distal coronary and aortic pressure during maximum hyperemia.

  2. Coronary Flow velocity Reserve (CRF)

    Time frame · 12 weeks

    Registry description

    CFR is a unitless index calculated as the ratio between the the mean transit time recorded at maximum hyperemia and at baseline using the thermodilution.

  3. Index of Microcirculatory Resistance (IMR)

    Time frame · 12 weeks

    Registry description

    IMR is a unitless index calculated by dividing the mean distal coronary pressure by the inverse of the mean transit time recorded using the thermodilution technique during maximum hyperemia

  4. Fractional flow reserve positive re-stenosis

    Time frame · 12 weeks

  5. Target lesion failure

    Time frame · 12 weeks

    Registry description

    Need of unplanned PCI in the treated stenosis or significant re-stenosis in the follow-up

  6. Acute coronary syndrome (ACS) and/or repeat revascularization

    Time frame · 12 weeks

  7. Late lumen loss/neointima thickness measured with OCT

    Time frame · 12 weeks

  8. Change in minimal lumen area by OCT

    Time frame · 12 weeks

  9. Left ventricular systolic and diastolic function assessed by echocardiography

    Time frame · 12 weeks

  10. Recovery from endothelial damage, measured by high resolution ultrasound, after PCI

    Time frame · 12 weeks

    Registry description

    Non-invasive ultrasound over the radialis artery after the PCI procedure using Standard 6-7F guiding catheters.

  11. Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels

    Time frame · 12 weeks

  12. Plasma markers of inflammation i.e., CRP, IL-1β, IL-6 and IL-8.

    Time frame · 12 weeks

  13. Plasma markers of matrix remodeling enzymes i.e., MMP-2 and MMP9

    Time frame · 12 weeks

  14. Circulating endothelial progenitor cells

    Time frame · 12 weeks

  15. Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS)

    Time frame · 12 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

4 results

Effects of exenatide on coronary stent's endothelialization in subjects with type 2 diabetes: a randomized controlled trial. The Rebuild study.

Santos-Pardo et al. 2023Cardiovascular diabetologycited by 1

PMID 38066597PMC10709975DOI 10.1186/s12933-023-02071-4PUB-38066597

CC BY4 results
Download PDFSee results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultEriksson L, Saxelin R, Rohl S, Roy J, Caidahl K, Nystrom T, Hedin U, Razuvaev A. Glucagon-Like Peptide-1 Receptor Activation Does not Affect Re-Endothelialization but Reduces Intimal Hyperplasia via Direct Effects on Smooth Muscle Cells in a Nondiabetic Model of Arterial Injury. J Vasc Res. 2015;52(1):41-52. doi: 10.1159/000381097. Epub 2015 May 7. PMID 25966620
  • ResultErdogdu O, Eriksson L, Xu H, Sjoholm A, Zhang Q, Nystrom T. Exendin-4 protects endothelial cells from lipoapoptosis by PKA, PI3K, eNOS, p38 MAPK, and JNK pathways. J Mol Endocrinol. 2013 Mar 18;50(2):229-41. doi: 10.1530/JME-12-0166. Print 2013 Apr. PMID 23343509
  • ResultErdogdu O, Nathanson D, Sjoholm A, Nystrom T, Zhang Q. Exendin-4 stimulates proliferation of human coronary artery endothelial cells through eNOS-, PKA- and PI3K/Akt-dependent pathways and requires GLP-1 receptor. Mol Cell Endocrinol. 2010 Aug 30;325(1-2):26-35. doi: 10.1016/j.mce.2010.04.022. Epub 2010 May 7. PMID 20452396
  • ResultErdogdu O, Eriksson L, Nystrom T, Sjoholm A, Zhang Q. Exendin-4 restores glucolipotoxicity-induced gene expression in human coronary artery endothelial cells. Biochem Biophys Res Commun. 2012 Mar 23;419(4):790-5. doi: 10.1016/j.bbrc.2012.02.106. Epub 2012 Feb 27. PMID 22390929
  • ResultNystrom T, Gutniak MK, Zhang Q, Zhang F, Holst JJ, Ahren B, Sjoholm A. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab. 2004 Dec;287(6):E1209-15. doi: 10.1152/ajpendo.00237.2004. Epub 2004 Sep 7. PMID 15353407
  • ResultDokken BB, Piermarini CV, Teachey MK, Gura MT, Dameff CJ, Heller BD, Krate J, Ashgar AM, Querin L, Mitchell JL, Hilwig RW, Kern KB. Glucagon-like peptide-1 preserves coronary microvascular endothelial function after cardiac arrest and resuscitation: potential antioxidant effects. Am J Physiol Heart Circ Physiol. 2013 Feb 15;304(4):H538-46. doi: 10.1152/ajpheart.00282.2012. Epub 2012 Dec 15. PMID 23241323
  • ResultGuagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005. PMID 20630463

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients eligible for PCI with application of DES, due to ACS. 2. Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs) 3. Male and female subjects 18-80 years. 4. HbA1c (accordingly to IFCC) 47 mmol/mol - 110 mmol/mol. 5. Signed informed consent form. Exclusion Criteria: 1. Type 1 diabetes (autoantibody positive). 2. Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors within 6 months 3. Known severe heart failure, classified as NYHA 4. 4. Active myocarditis; malfunctioning artificial heart valve. 5. History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block. 6. Supine systolic blood pressure \<85 mm Hg or \>200 mm Hg at screening. 7. Primary renal impairment, creatinine clearance \< 45 ml/min if treated with metformin. 8. Uncorrected hypokalemia or hyperkalemia (potassium \<3.5 mmol/l or \>5.5 mmol/l). 9. Significant anemia (Hb \< 90 g/l) 10. Severe gastrointestinal disease, including gastroparesis. As judged by the Investigator. 11. Body mass index (BMI) \> 45 kg/m2. 12. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial. 13. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant. 14. Current drug and alcohol abuse. 15. History of acute or chronic pancreatitis 16. Subjects considered by the Investigator to be unsuitable for the study.

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