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

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: insulin glulisine (Drug); insulin aspart (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Spectrum Health Hospitals

Official(s) and/or principal investigator(s):
Ayse P Cemeroglu, MD, Principal Investigator, Affiliation: Helen DeVos Childrens Hospital

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

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 design: Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions

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.

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

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

Helen DeVos Childrens Hospital, Grand Rapids, Michigan 49503, United States

Starting date: June 2009
Last updated: April 3, 2014