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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Collaborator: Helen DeVos Children's Hospital
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin, Globin Zinc; Insulin, Long-Acting

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