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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00798590
• Other study ID #: NA_00022551
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: November 25, 2008
• Last updated: March 25, 2010
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hypoglycemia

Intervention

Drug:
• Glucagon-Like Peptide-1
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
• Saline
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Society of Critical Care Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.		2 years	No