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

This study has been completed.
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by (Responsible Party):
Ayse Cemeroglu, Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00913497
First received: June 2, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: insulin glulisine
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • 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: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: insulin glulisine 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
Other Name: (Apidra®)
Active Comparator: insulin aspart 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.
Other Name: (NovoLog®)

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.

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913497

Locations
United States, Michigan
Helen DeVos Childrens Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Investigators
Principal Investigator: Ayse P Cemeroglu, MD Helen DeVos Childrens Hospital
  More Information

No publications provided

Responsible Party: Ayse Cemeroglu, Physician, Endocrine Diabetes, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT00913497     History of Changes
Other Study ID Numbers: 2009-089
Study First Received: June 2, 2009
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:
Type 1 diabetes mellitus in children
insulin glulisine
insulin aspart
post prandial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014