Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00798590Other idNA_00022551

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI left JHU

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 19 participants (actual)
Sponsor: Johns Hopkins University · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Jun 2010
Completion: Jun 2011
First posted: 26 Nov 2008 (estimated)
Last update posted: 2 Jul 2017
Conditions: Critically Ill · Hypoglycemia

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082009201020112012

Ph 2
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
NCT00798590
Dec 2008 to Jun 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Glucagon-Like Peptide-1Drug
SalineDrug

Arms2

Experimental
GLP-1
Placebo comparator
Saline

Primary outcomes1

Outcomes the sponsor listed as 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.
Time frame · 2 years

Secondary outcomes(1)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 2 years

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

Group	Value
GLP-1	not posted
Saline	not posted

Secondary and other outcome results(1)

Secondary outcome· 2 years

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

Group	Value
GLP-1	not posted
Saline	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GLP-1Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.	0 / 0	0 / 0	0 / 0
SalineSaline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.	0 / 0	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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