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

Spectrum Health Hospitals

Status and phase

Completed

Phase 4

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: insulin glulisine

Drug: insulin aspart

Study type

Interventional

Funder types

Other

Identifiers

NCT00913497

2009-089

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

4 to 11 years old

Volunteers

No Healthy Volunteers

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