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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373216
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : February 2, 2016
Eli Lilly and Company
Information provided by (Responsible Party):
Martin Haluzik, Charles University, Czech Republic

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Decreased Left Ventricular Function Drug: Exenatide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs
Study Start Date : June 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide
Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment
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

No Intervention: Control
Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment

Primary Outcome Measures :
  1. Cardiac function - echocardiographic parameters [ Time Frame: 90 days after administration of exenatide ]
    • cardiac chamber dimensions
    • left ventricular systolic function
    • left ventricular diastolic function
    • right ventricular systolic function

Secondary Outcome Measures :
  1. Number of participants with adverse effects [ Time Frame: 90 days after administration of exenatide ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373216

Czech Republic
General University Hospital
Prague, Czech Republic, 128 08
Sponsors and Collaborators
Charles University, Czech Republic
Eli Lilly and Company
Principal Investigator: Martin Haluzik, D.Sc. General University Hospital, Charles University, Prague

Responsible Party: Martin Haluzik, Prof. Martin Haluzik, MD DSc, Charles University, Czech Republic Identifier: NCT01373216     History of Changes
Other Study ID Numbers: H8O-CY-O027
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists