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

NCT00798590 | Terminated Phase 2 Results DMC

• 1 other identifier: NA_00022551
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Hypoglycemia

Keywords

Intensive insulin therapy (IIT); Insulin infusion; Tight glycemic control; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment

  2 years

Study Arms (2)

GLP-1

EXPERIMENTAL

Drug: Glucagon-Like Peptide-1

Saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Glucagon-Like Peptide-1 DRUG

5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.

Also known as: GLP-1

GLP-1

Saline DRUG

5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Saline

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age \> 21 to 75 years of age.
• Able to obtain patient or proxy consent.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Society of Critical Care Medicine: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Critical Illness; Hypoglycemia

Interventions

Glucagon-Like Peptide 1; Sodium Chloride

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Johns Hopkins University Clinical Trials Program
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Study Officials

• Dariush Elahi, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)