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

NCT ID: NCT00913497

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-01-31

Brief Summary

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

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

insulin glulisine

Group Type: ACTIVE_COMPARATOR

insulin glulisine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

insulin aspart

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

(Apidra®); (NovoLog®)

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

• 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

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;

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helen DeVos Children's Hospital

OTHER

Sponsor Role: collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayse P Cemeroglu, MD

Role: PRINCIPAL_INVESTIGATOR

Helen DeVos Childrens Hospital

Locations

Helen DeVos Childrens Hospital

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

2009-089

Identifier Type: -

Identifier Source: org_study_id