Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Saint Luke's Health System.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Saint Luke's Health System
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT00736229
First received: August 14, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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Purpose
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperglycemia Acute Coronary Syndromes Myocardial Infarction |
Drug: Exenatide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit |
Resource links provided by NLM:
Further study details as provided by Saint Luke's Health System:
Primary Outcome Measures:
- Average glucose value during coronary ICU stay [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of hypoglycemic episodes / total number of glucose measurements [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
- Number of subjects with >1 hypoglycemic episode / total number of subjects [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
- Serious adverse events (death, life-threatening event, prolonged hospitalization, disability or incapacity, congenital anomaly or birth defect, non-life threatening event) after discontinuation of study drug [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide |
Drug: Exenatide
0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
|
Detailed Description:
Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes. Clinical practice guidelines from the American College of Cardiology/American Heart Association for the treatment of patients with acute coronary syndromes call for treatment to achieve preprandial glucose <110 mg/dL, a maximum daily target <180 mg/dL, and a post-discharge hemoglobin A1c <7%. Initiation of aggressive insulin therapy is also warranted to achieve blood glucose <150 mg/dL during days 0-3 and 80-110 mg/dL when possible thereafter. To date, no studies have been conducted assessing the efficacy of intravenous exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Admission to coronary ICU
- Admission blood glucose 140-299 mg/dL
- Primary cardiovascular diagnosis by attending physician
- Under primary care of cardiology service
- Age > 18 years old
- Ventilator independent
- Able to provide informed consent
Exclusion Criteria:
- Admission blood glucose < 140 or > 300 mg/dL
- Ventilator dependent
- Unconscious sedation
- Type 1 diabetes
- Known pregnancy
- Admitted to CICU for right heart cath to measure hemodynamics prior to transplant
- Post transplant procedure
- Currently enrolled in another clinical trial
- Unable to provide informed consent
- Creatinine clearance < 30 mL/min
- On insulin treatment except for monotherapy with long-acting basal insulin (e.g., insulin glargine [Lantus®] or detemir [Levemir®])
- Gastroparesis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736229
Contacts
| Contact: Cheryl Rutherford, RN | 816-932-2000 ext 6275 | cjrutherford@saint-lukes.org |
| Contact: Kathryn Safley, RN | 816-932-2000 ext 9885 | ksafley@saint-lukes.org |
Locations
| United States, Missouri | |
| Mid America Heart Institute Saint Luke's Health System | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Cheryl Rutherford, RN 816-932-2000 ext 6275 cjrutherford@saint-lukes.org | |
| Principal Investigator: Steve Marso, MD | |
Sponsors and Collaborators
Saint Luke's Health System
Amylin Pharmaceuticals, LLC.
More Information
No publications provided
| Responsible Party: | Steven P. Marso, MD, Mid America Heart Institute Saint Lukes' Health System |
| ClinicalTrials.gov Identifier: | NCT00736229 History of Changes |
| Other Study ID Numbers: | 08-206 |
| Study First Received: | August 14, 2008 |
| Last Updated: | August 14, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Saint Luke's Health System:
|
hyperglycemia acute coronary syndromes myocardial infarction |
Additional relevant MeSH terms:
|
Hyperglycemia Infarction Myocardial Infarction Acute Coronary Syndrome Glucose Metabolism Disorders Metabolic Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013