To determine whether insulin glulisine decreases the breakfast post prandial glycemic
excursion in comparison to insulin aspart.
Drug: insulin glulisine
Drug: insulin aspart
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00913497
Ages eligible for Study
4 Years to 11 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT00913497
United States (1)
Helen DeVos Childrens Hospital
Grand Rapids, Michigan, United States, 49503
View full eligibility
Tris trial is registered with FDA with number: NCT00913497. The sponsor of the trial is Spectrum Health Hospitals and it is looking for 16 volunteers for the current phase.
Official trial 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
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