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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Society of Critical Care Medicine
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00798590
First received: November 25, 2008
Last updated: March 25, 2010
Last verified: March 2010

November 25, 2008
March 25, 2010
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00798590 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy of 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% 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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.
    Other Name: Saline
  • 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.
 
Enrolling by invitation
180
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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00798590
NA_00022551
Yes
Dariush Elahi, Johns Hopkins University School of Medicine
Johns Hopkins University
Society of Critical Care Medicine
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
Johns Hopkins University
March 2010

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