- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00913497
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
September 14, 2023 updated by: Spectrum Health Hospitals
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
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Helen DeVos Childrens Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 11 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
Other Names:
|
Active Comparator: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days
|
Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)
|
measured daily at baseline, 2 and 4 hours post prandial for 20 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of Hypoglycemia;
Time Frame: measured daily at 2 and 4 hours postprandial for 20 days
|
measured daily at 2 and 4 hours postprandial for 20 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayse P Cemeroglu, MD, Helen DeVos Childrens Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 3, 2009
First Posted (Estimated)
June 4, 2009
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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