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

Phase 2

Terminated

• Conditions: Hypoglycemia; Critically Ill
• Interventions: Drug: Glucagon-Like Peptide-1; Drug: Saline

• Registration Number: NCT00798590
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2008-12
• Primary Completion: 2010-06
• Study Completion: 2011-06
• Results First Submitted: 2017-05-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

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Exclusion Criteria

• Current diagnosis of malignancy.
• Type 1 diabetes.
• Inability to obtain informed consent.
• On any Phase 1 trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLP-1	Glucagon-Like Peptide-1	-
Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.	2 years

Secondary Outcome Measures

Name	Time	Method
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment	2 years

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States