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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: insulin glulisine; Drug: insulin aspart

• Registration Number: NCT00913497
• Lead Sponsor: Spectrum Health Hospitals

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2023-07-12
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Results First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
insulin glulisine	insulin glulisine	-
insulin aspart	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
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	Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)

Secondary Outcome Measures

Name	Time	Method
Occurrence of Hypoglycemia;	measured daily at 2 and 4 hours postprandial for 20 days

Trial Locations

Locations (1)

Helen DeVos Childrens Hospital; 🇺🇸 Grand Rapids, Michigan, United States