Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

Coronary Artery Disease Clinical Trial

— Executive  

Official title:

EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373216
• Other study ID #: H8O-CY-O027
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2011
• Last updated: January 31, 2016
• Start date: June 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• elective coronary artery bypass grafting operation (CABG)

• decreased left ventricular (LV) systolic function (EF LV = 50%)

• Age 18 to 85

• Signed informed consent

• Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)

Exclusion Criteria:

• allergy to exenatide

• allergy to insulin

• mental incapacity or language barrier

• use of incretin-based therapies <3 months before inclusion in the study

• diabetic ketoacidosis

• established autonomic neuropathy

• history of acute pancreatitis or severe disease of digestive tract

• renal failure (preoperative creatinine = 180 umol/l)

• liver failure (coagulation times more than 1.5 times higher without use of anticoagulants)

• cardiac surgical procedure on valve, thoracic aorta or MAZE procedure

• pregnancy and lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Decreased Left Ventricular Function
• Myocardial Ischemia

Intervention

Drug:
• Exenatide
Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours

Locations

Country	Name	City	State
Czech Republic	General University Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Eli Lilly and Company

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function - echocardiographic parameters	cardiac chamber dimensions; left ventricular systolic function; left ventricular diastolic function; right ventricular systolic function	90 days after administration of exenatide	No
Secondary	Number of participants with adverse effects		90 days after administration of exenatide	Yes