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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913497
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : April 4, 2014
Helen DeVos Children's Hospital
Information provided by (Responsible Party):
Ayse Cemeroglu, Spectrum Health Hospitals

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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®)

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00913497

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United States, Michigan
Helen DeVos Childrens Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Helen DeVos Children's Hospital
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Principal Investigator: Ayse P Cemeroglu, MD Helen DeVos Childrens Hospital
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Responsible Party: Ayse Cemeroglu, Physician, Endocrine Diabetes, Spectrum Health Hospitals Identifier: NCT00913497    
Other Study ID Numbers: 2009-089
First Posted: June 4, 2009    Key Record Dates
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs