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The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798590
First Posted: November 26, 2008
Last Update Posted: July 2, 2017
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.
Collaborator:
Society of Critical Care Medicine
Information provided by (Responsible Party):
Johns Hopkins University
November 25, 2008
November 26, 2008
May 1, 2017
July 2, 2017
July 2, 2017
December 2008
June 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00798590 on ClinicalTrials.gov Archive Site
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment [ Time Frame: 2 years ]
Compare the # of hypoglycemic events between GLP-1/placebo treatment;Amount of meds in the control of homeostasis;Death in the ICU/in-hospital;Time of ICU stay/hospitalization;ICU infection rate;Time of ventilator support to time of extubation. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Critically Ill
  • Hypoglycemia
  • Drug: Glucagon-Like Peptide-1
    5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
    Other Name: GLP-1
  • Drug: Saline
    5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
  • Experimental: GLP-1
    Intervention: Drug: Glucagon-Like Peptide-1
  • Placebo Comparator: Saline
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
June 2011
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00798590
NA_00022551
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Society of Critical Care Medicine
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
Johns Hopkins University
June 2017

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