Back to resultsThe Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
Primary Purpose
Critically Ill, Hypoglycemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glucagon-Like Peptide-1
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill focused on measuring Intensive insulin therapy (IIT), Insulin infusion, Tight glycemic control, Intensive Care Units
Eligibility Criteria
Inclusion Criteria:
- Men and women age > 21 to 75 years of age.
- All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
- Able to obtain patient or proxy consent.
Exclusion Criteria:
- Current diagnosis of malignancy.
- Type 1 diabetes.
- Inability to obtain informed consent.
- On any Phase 1 trial.
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GLP-1
Saline
Arm Description
Outcomes
Primary Outcome Measures
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
Secondary Outcome Measures
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
Full Information
NCT ID
NCT00798590
First Posted
November 25, 2008
Last Updated
June 1, 2017
Sponsor
Johns Hopkins University
Collaborators
Society of Critical Care Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00798590
Brief Title
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
Official Title
The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left JHU
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Society of Critical Care Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
Detailed Description
All patients whom on admission to the ICU (surgical, burn, & cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Hypoglycemia
Keywords
Intensive insulin therapy (IIT), Insulin infusion, Tight glycemic control, Intensive Care Units
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-1
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Glucagon-Like Peptide-1
Other Intervention Name(s)
GLP-1
Intervention Description
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Primary Outcome Measure Information:
Title
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age > 21 to 75 years of age.
All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
Able to obtain patient or proxy consent.
Exclusion Criteria:
Current diagnosis of malignancy.
Type 1 diabetes.
Inability to obtain informed consent.
On any Phase 1 trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariush Elahi, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
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