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

• ClinicalTrials.gov Identifier: NCT00913497
• Recruitment Status: Completed
• First Posted: June 4, 2009
• Last Update Posted: April 4, 2014
• Sponsor: Spectrum Health Hospitals
• Collaborator: Helen DeVos Children's Hospital
• Information provided by (Responsible Party): Ayse Cemeroglu, Spectrum Health Hospitals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Drug: insulin glulisine; Drug: insulin aspart	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: June 2009
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
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®)

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 45 days ]

Secondary Outcome Measures :

1. Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions [ Time Frame: 45 days ]

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ayse Cemeroglu, Physician, Endocrine Diabetes, Spectrum Health Hospitals
• ClinicalTrials.gov Identifier: NCT00913497
• Other Study ID Numbers: 2009-089
• First Posted: June 4, 2009
• Last Update Posted: April 4, 2014
• Last Verified: April 2014

Keywords provided by Ayse Cemeroglu, 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; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine; Hypoglycemic Agents; Physiological Effects of Drugs