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

NCT00913497 | Completed Phase 4 Results

• 1 other identifier: 2009-089
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus in children; insulin glulisine; insulin aspart; post prandial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence of Hypoglycemia;

  measured daily at 2 and 4 hours postprandial for 20 days

Study Arms (2)

insulin glulisine

ACTIVE COMPARATOR

Drug: insulin glulisine

insulin aspart

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

insulin glulisine 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

Also known as: (Apidra®)

insulin glulisine

insulin aspart 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.

Also known as: (NovoLog®)

insulin aspart

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Corewell Health West: lead
• Helen DeVos Children's Hospital: collaborator

Study Sites (1)

Helen DeVos Childrens Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This study was completed over 10 years ago, raw data is no longer available, the results reported in this entry are based on the published document for the trial that was published in 2013. This is the only information that is available for reporting. Per the published works, the target enrollment was met and data analyzed.

Results Point of Contact

• Title: Esther Peariso
• Organization: Corewell Health

esther.peariso@corewellhealth.org

6164860358

Study Officials

• Ayse P Cemeroglu, MD

  Helen DeVos Childrens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Locations

US (1)