Effect of exenatid on microcirculation in patients with type 2 diabetes mellitus and coronary artery disease

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008367-95-SE

Enrollment

Registered

2009-02-12

Start date

2009-03-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 2 diabetes and coronary artery disease.

Interventions

Trade Name: Byetta Product Name: Byetta Product Code: Byetta Pharmaceutical Form: Injection* INN or Proposed INN: Exenatide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus 2. Treatment with Metformin and/or SU at least 3 months prior to randomisation 3. Glycated haemoglobin >6.0% 4. Coronary artery disease, i.e. previous MI, stable angina, acute coronary syndrome 5. Signed written inform consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age >75 or 10% 3. Childbearing potential 4. Impaired renal function with creatinine clearance <30 ml/min 5. Current or previous treatment with exenatid 6. Current insulin use 7. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol 8. Participant in an ongoing study

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment.;Secondary Objective: To study the effects of exenatid on myocardial and skin microcirculation, respectively, evaluated by Coronary Flow Reserve (CFR), laser Doppler fluxmetry (LDF), Dynamic Capillaroscopy and transcutaneous oxygen tension (TcPO2).;Primary end point(s): The primary objective of the trial is to test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment.	—

Measure

Time frame

Main Objective: To test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment.;Secondary Objective: To study the effects of exenatid on myocardial and skin microcirculation, respectively, evaluated by Coronary Flow Reserve (CFR), laser Doppler fluxmetry (LDF), Dynamic Capillaroscopy and transcutaneous oxygen tension (TcPO2).;Primary end point(s): The primary objective of the trial is to test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026