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
  Purpose

The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.


Condition Intervention Phase
Critically Ill
Hypoglycemia
Drug: Glucagon-Like Peptide-1
Drug: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: December 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1 Drug: Glucagon-Like Peptide-1
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Other Name: GLP-1
Placebo Comparator: Saline Drug: Saline
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Other Name: Saline

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% 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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798590

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Society of Critical Care Medicine
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Dariush Elahi, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
Study First Received: November 25, 2008
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Intensive insulin therapy (IIT)
Insulin infusion
Tight glycemic control
Intensive Care Units

Additional relevant MeSH terms:
Critical Illness
Hypoglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on April 16, 2014