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

Type 1 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913497
• Other study ID #: 2009-089
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
United States	Helen DeVos Childrens Hospital	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Helen DeVos Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Occurrence of Hypoglycemia;		measured daily at 2 and 4 hours postprandial for 20 days