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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)
Society of Critical Care Medicine
Information provided by (Responsible Party):
Johns Hopkins University Identifier:
First received: November 25, 2008
Last updated: June 1, 2017
Last verified: June 2017
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment [ Time Frame: 2 years ]

Enrollment: 19
Study Start Date: December 2008
Study Completion Date: June 2011
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.

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.

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00798590

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

Responsible Party: Johns Hopkins University Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
Study First Received: November 25, 2008
Results First Received: May 1, 2017
Last Updated: June 1, 2017

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins processed this record on September 19, 2017