The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
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ClinicalTrials.gov Identifier: NCT00913497 |
Recruitment Status :
Completed
First Posted : June 4, 2009
Last Update Posted : April 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: insulin glulisine Drug: insulin aspart | Phase 4 |
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 |

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®) |
- 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 ]
- Incidence of symptomatic hypoglycemia; hyperglycemia with ketonuria; systemic allergic reactions; localized injection site reactions [ Time Frame: 45 days ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00913497
United States, Michigan | |
Helen DeVos Childrens Hospital | |
Grand Rapids, Michigan, United States, 49503 |
Principal Investigator: | Ayse P Cemeroglu, MD | Helen DeVos Childrens Hospital |
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 Key Record Dates |
Last Update Posted: | April 4, 2014 |
Last Verified: | April 2014 |
Type 1 diabetes mellitus in children insulin glulisine insulin aspart post prandial |
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 |