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Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia

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ClinicalTrials.gov Identifier: NCT00835328
Recruitment Status : Suspended (Enrollment is pending further analysis of the stability of exendin-(9-39) at higher concentrations.)
First Posted : February 3, 2009
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date July 9, 2019
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
Glucose infusion rate during the last 2 hours of infusion of exendin-(9-39) [ Time Frame: 7-9 hours after start of infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Glucose infusion rate over a period of 12 hours [ Time Frame: 12 hours ]
Change History Complete list of historical versions of study NCT00835328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Plasma glucose 1 hour after initiation of infusion, [ Time Frame: 1 hour after start of infusion ]
  • Insulin Level [ Time Frame: 0,1,5,9,hour during 9 hour infusion ]
  • Plasma levels of exendin-(9-39) [ Time Frame: 1,5,9, +15,10,12,14 hour during and post infusion ]
  • Betahydroxybutyrate levels [ Time Frame: 0,1,5,9, during 9 hour infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • Plasma glucagon levels [ Time Frame: 12 hours ]
  • Plasma Insulin Level [ Time Frame: 12 hours ]
  • Plasma levels of exendin-(9-39) [ Time Frame: 12 hours ]
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2015)
  • Safety variables [ Time Frame: 2 days (baseline, study end) ]
    12 lead electrocardiograms,laboratory safety test(hematology, chemistry and urinalysis)
  • safety variable [ Time Frame: 9 hours ]
    Vital signs, adverse events
  • safety variables [ Time Frame: baseline ]
    physical examination
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia
Official Title  ICMJE Role of GLP-1 In Congenital Hyperinsulinism: Effect Of Exendin-(9-39)On Glucose Requirements To Maintain Euglycemia
Brief Summary The purpose of this study is to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy
Detailed Description This is an open label sudy to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy and to determine therapeutic plasma levels,plasma half life and pharmacokinetics of exendin-(9-39)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Hyperinsulinism
Intervention  ICMJE
  • Drug: exendin-(9-39)
    exendin-(9-39) 1000-30000pmol/kg/min (0.2-6mg/kg/hr) Intravenous infusion over 9 hours
  • Other: placebo
    normal saline Intravenous infusion over 9 hours
Study Arms  ICMJE
  • Experimental: exendin-(9-39)
    exendin-(9-39) 1000-30000pmol/kg/min (0.2-6mg/kg/hr) Intravenous infusion over 9 hours
    Intervention: Drug: exendin-(9-39)
  • Placebo Comparator: placebo
    intravenous infusion of normal saline over 9 hours
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2009)
30
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of congenital hyperinsulinism (based on clinical criteria: insulin, beta hydroxybutyrate, and/or free fatty acid plasma levels at the time of hypoglycemia, and/or glycemic response to glucagon at the time of hypoglycemia)
  • Age: from birth to 12 months
  • Failure to respond to diazoxide (defined as the failure to maintain blood glucose and octreotide (defined as the failure to maintain blood glucose ≥ 70 mg/dL without supraphysiologic rates of glucose infusion> 4-5 mg/Kg/min)

Exclusion Criteria:

  • Evidence of a medical condition that might alter results, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
  • Current therapy at the time of initiation of study procedures with medications that affect glucose metabolism, such as high dose glucocorticoids, ß-agonists, glucagon, diazoxide and octreotide. Subjects will be eligible to participate 4 hours after glucagon is discontinued, 24 hours after the last dose of octreotide and 72 hours after last dose of diazoxide,
  • Subjects with suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835328
Other Study ID Numbers  ICMJE 2008-10-6256
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diva De Leon, Children's Hospital of Philadelphia
Study Sponsor  ICMJE Diva De Leon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diva D De Leon, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP