Clinical trial
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
Name
2009-089
Description
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
Trial arms
Trial start
2009-06-01
Estimated PCD
2012-01-01
Trial end
2012-01-01
Status
Completed
Phase
Early phase I
Treatment
insulin glulisine
Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days
Arms:
insulin glulisine
Other names:
(Apidra®)
insulin aspart
Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
Arms:
insulin aspart
Other names:
(NovoLog®)
Size
16
Primary endpoint
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
measured daily at baseline, 2 and 4 hours post prandial for 20 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}
Updated at
2023-09-18
1 organization
2 products
1 indication
Organization
Spectrum Health HospitalsProduct
Insulin GlulisineIndication
Type 1 Diabetes MellitusProduct
Insulin Aspart