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The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

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ClinicalTrials.gov Identifier: NCT00913497
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by (Responsible Party):
Ayse Cemeroglu, Spectrum Health Hospitals

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date April 4, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Difference in the two hour and four hour post prandial blood glucose levels following administration of insulin glulisine versus insulin aspart at the end of the twenty study days [ Time Frame: 45 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Difference in the two hour and four hour post prandial blood glucose levels following administration of insulin glulisine versus insulin aspart at the end of the twenty study days [ Time Frame: 20 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions [ Time Frame: 45 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions [ Time Frame: 20 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Official Title  ICMJE Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
Brief Summary To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
Detailed Description This is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: insulin glulisine
    Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days
    Other Name: (Apidra®)
  • Drug: insulin aspart
    Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
    Other Name: (NovoLog®)
Study Arms  ICMJE
  • Active Comparator: insulin glulisine
    Intervention: Drug: insulin glulisine
  • Active Comparator: insulin aspart
    Intervention: Drug: insulin aspart
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
24
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • current patient in the Helen DeVos Children's Hospital Diabetes Clinic;
  • ages 4-11 years;
  • prepubertal (Tanner Stage I);
  • diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;
  • at least six months from date of diagnosis of type 1 diabetes mellitus;
  • TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start;
  • HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment;
  • at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin

Exclusion Criteria:

  • pubertal (Tanner stage 2 or greater);
  • concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;
  • receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;
  • intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;
  • use of any medication to treat diabetes other than those listed under in inclusion criteria;
  • potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (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 NCT00913497
Other Study ID Numbers  ICMJE 2009-089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ayse Cemeroglu, Spectrum Health Hospitals
Study Sponsor  ICMJE Spectrum Health Hospitals
Collaborators  ICMJE Helen DeVos Children's Hospital
Investigators  ICMJE
Principal Investigator: Ayse P Cemeroglu, MD Helen DeVos Childrens Hospital
PRS Account Spectrum Health Hospitals
Verification Date April 2014

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