Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes mellitus in children, insulin glulisine, insulin aspart, post prandial
Brief summary
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
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.
Interventions
DRUGinsulin 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
DRUGinsulin 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.
Sponsors
Helen DeVos Children's Hospital
Corewell Health West
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | measured daily at baseline, 2 and 4 hours post prandial for 20 days | Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating) |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Hypoglycemia; | measured daily at 2 and 4 hours postprandial for 20 days |
Countries
United States
Participant flow
Pre-assignment details
This study is indicated to technically be a crossover study, however, participants were asked to take one medication on even days and the other on odd days. There was no washout period.
Participants by arm
| Arm | Count |
|---|---|
| All Participants 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 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 8.8 years STANDARD_DEVIATION 0.58 | — |
| BMI | 17.82 kg/m2 STANDARD_DEVIATION 2.47 | — |
| HbA1C | 7.7 percentage of total hemoglobin STANDARD_DEVIATION 0.54 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 8 / 13 | 9 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
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)
Time frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glulisine | 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 | Baseline blood sugar (prior to eating) | 136.4 mg/dL | Standard Deviation 15.7 |
| Insulin Glulisine | 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 | 2 hour postprandial Blood Glucose excursion (2h measurement minus baseline) | 113.5 mg/dL | Standard Deviation 65.2 |
| Insulin Glulisine | 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 | 4 hour postprandial blood glucose excursion (4h measurement minus baseline) | 5.5 mg/dL | Standard Deviation 36.5 |
| Insulin Aspart | 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 | Baseline blood sugar (prior to eating) | 133.4 mg/dL | Standard Deviation 14.7 |
| Insulin Aspart | 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 | 2 hour postprandial Blood Glucose excursion (2h measurement minus baseline) | 98.6 mg/dL | Standard Deviation 66.9 |
| Insulin Aspart | 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 | 4 hour postprandial blood glucose excursion (4h measurement minus baseline) | 4.4 mg/dL | Standard Deviation 36.7 |
Secondary
Occurrence of Hypoglycemia;
Time frame: measured daily at 2 and 4 hours postprandial for 20 days
Population: analysis data is gathered from the published article, no further data is available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glulisine | Occurrence of Hypoglycemia; | 2 hour post prandial hypoglycemia | 8 number of events |
| Insulin Glulisine | Occurrence of Hypoglycemia; | 4 hour post prandial hypoglycemia | 19 number of events |
| Insulin Aspart | Occurrence of Hypoglycemia; | 2 hour post prandial hypoglycemia | 9 number of events |
| Insulin Aspart | Occurrence of Hypoglycemia; | 4 hour post prandial hypoglycemia | 26 number of events |