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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Martin Haluzik, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01373216
First received: June 10, 2011
Last updated: March 18, 2014
Last verified: March 2014

June 10, 2011
March 18, 2014
June 2011
April 2014   (final data collection date for primary outcome measure)
Cardiac function - echocardiographic parameters [ Time Frame: 90 days after administration of exenatide ] [ Designated as safety issue: No ]
  • cardiac chamber dimensions
  • left ventricular systolic function
  • left ventricular diastolic function
  • right ventricular systolic function
Same as current
Complete list of historical versions of study NCT01373216 on ClinicalTrials.gov Archive Site
Number of participants with adverse effects [ Time Frame: 90 days after administration of exenatide ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Diabetic Patients With Aortocoronary Bypass
EXEnatide in Diabetic Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs

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 diabetic 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 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 type 2 diabetics with coronary atherosclerosis and left ventricular dysfunction elective undergoing 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Left Ventricular Dysfunction
  • Type 2 Diabetes Mellitus
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
  • Experimental: Exenatide
    Patients with left ventricular dysfunction undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment
    Intervention: Drug: Exenatide
  • No Intervention: Control
    Patients with left ventricular dysfunction undergoing elective coronary artery by-pass grafting receiving standard treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
38
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • established diagnosis of type 2 diabetes mellitus treated by oral antidiabetic agents
  • elective coronary artery bypass grafting operation (CABG)
  • left ventricular (LV) systolic dysfunction (EF LV ≤ 40%)
  • Age 18 to 85

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)
  • chronic intensified insulin regimen treatment (more than two insulin injections/day)
  • cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
  • pregnancy and lactation
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01373216
H8O-CY-O027
Yes
Martin Haluzik, Charles University, Czech Republic
Charles University, Czech Republic
Eli Lilly and Company
Principal Investigator: Martin Haluzik, D.Sc. General University Hospital, Charles University, Prague
Charles University, Czech Republic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP