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

Study Overview
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Brief Summary
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To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: insulin glulisine
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: insulin glulisine<br> | Drug: insulin glulisine<br>* 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<br>* Other names: (Apidra®);|
| Active Comparator: insulin aspart<br> | Drug: insulin aspart<br>* 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.<br>* Other names: (NovoLog®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating) | measured daily at baseline, 2 and 4 hours post prandial for 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Hypoglycemia; |  | measured daily at 2 and 4 hours postprandial for 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes mellitus in children, insulin glulisine, insulin aspart, post prandial