DRUG
Bydureon
2 mg Once Weekly
Status
Completed
Phase
Phase 4
Enrollment
38
Locations
1
Results
Not posted
Publications
8
Study summary
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.
Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI. Primary objectives: To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts Secondary objectives: To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions
Interventions
DRUG
2 mg Once Weekly
DRUG
Humulin kwickpen 10U QD at bedtime
DRUG
Metformin 1g BID
Timeline
First posted
Dec 3, 2015
Study start
Dec 2015
Primary completion
Aug 2022
Study completion
Oct 2022
Results posted
Not reported
Registry updated
Apr 20, 2023
Outcomes
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
Fractional Flow Reserve (FFR)
Time frame · 12 weeks
FFR is a unitless index calculated as the ratio between distal coronary and aortic pressure during maximum hyperemia.
Coronary Flow velocity Reserve (CRF)
Time frame · 12 weeks
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.
Index of Microcirculatory Resistance (IMR)
Time frame · 12 weeks
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
Fractional flow reserve positive re-stenosis
Time frame · 12 weeks
Target lesion failure
Time frame · 12 weeks
Need of unplanned PCI in the treated stenosis or significant re-stenosis in the follow-up
Acute coronary syndrome (ACS) and/or repeat revascularization
Time frame · 12 weeks
Late lumen loss/neointima thickness measured with OCT
Time frame · 12 weeks
Change in minimal lumen area by OCT
Time frame · 12 weeks
Left ventricular systolic and diastolic function assessed by echocardiography
Time frame · 12 weeks
Recovery from endothelial damage, measured by high resolution ultrasound, after PCI
Time frame · 12 weeks
Non-invasive ultrasound over the radialis artery after the PCI procedure using Standard 6-7F guiding catheters.
Eligibility
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.
Study locations
Sweden. Showing up to 24 locations stored in the fast local snapshot.
Dept of clinical science and education Karolinska Institutet Södersjukhuset
Stockholm, Other, Sweden
Publications
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