Clinical trial NCT00913497: The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus in children
insulin glulisine
insulin aspart
post prandial
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
First posted: 2009-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: measured daily at baseline, 2 and 4 hours post prandial for 20 days
Secondary outcomes:
measure: Occurrence of Hypoglycemia;
timeFrame: measured daily at 2 and 4 hours postprandial for 20 days
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Helen DeVos Childrens Hospital
state: Michigan
Study officials:
affiliation: Helen DeVos Childrens Hospital
name: Ayse P Cemeroglu, MD
role: PRINCIPAL_INVESTIGATOR
References: