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

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ClinicalTrials.gov Identifier: NCT00798590
Recruitment Status : Terminated (PI left JHU)
First Posted : November 26, 2008
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Critically Ill
Hypoglycemia
Interventions: Drug: Glucagon-Like Peptide-1
Drug: Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    GLP-1   Saline
STARTED   11   8 
COMPLETED   0   0 
NOT COMPLETED   11   8 
P.I, Left institution. Study terminated                11                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GLP-1 Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Saline Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Total Total of all reporting groups

Baseline Measures
   GLP-1   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   8   19 
Age, Customized 
[Units: Participants]
     
>=21 and <=75   11   8   19 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1   9.1%      5  62.5%      6  31.6% 
Male      10  90.9%      3  37.5%      13  68.4% 
Region of Enrollment 
[Units: Participants]
     
United States   11   8   19 


  Outcome Measures

1.  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 ]

2.  Secondary:   Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins University Clinical Trials Program
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: May 1, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017