View Clinical Trial (Medical Research Study)
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
| City: |
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Grand Rapids |
| State: |
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Michigan |
| Zip Code: |
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49503 |
| Conditions: |
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Type 1 Diabetes Mellitus |
| Purpose: |
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To determine whether insulin glulisine decreases the breakfast post prandial glycemic
excursion in comparison to insulin aspart.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00913497 |
| Primary Contact: |
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Principal Investigator
Ayse P Cemeroglu, MD
Helen DeVos Childrens Hospital
Lora E. Kleis, RN
Phone: 616-391-2419
Email: lora.kleis@devoschildrens.org
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| Backup Contact: |
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Email: ayse.cemeroglu@devoschildrens.org
Ayse P. Cemeroglu, MD
Phone: 616- 391-3933
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| Location Contact: |
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Grand Rapids, Michigan 49503
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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