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

Conditions: Patients with type 2 diabetes and coronary artery disease.

Registration Number: EUCTR2008-008367-95-SE

Lead Sponsor: Karolinska Institutet, Inst för kliniska vetenskaper, Danderyds sjukhus

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

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

1.Age >75 or <18 years
2.Glycated haemoglobin >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures