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

Johns Hopkins University

Status and phase: Terminated; Phase 2

Conditions: Hypoglycemia; Critically Ill

Treatments: Drug: Glucagon-Like Peptide-1; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00798590

NA_00022551

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

GLP-1

Experimental group

Treatment:

Drug: Glucagon-Like Peptide-1

Saline

Placebo Comparator group

Treatment:

Drug: Saline