Overview

Evaluation of Pharmacokinetics and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to evaluate the variations in pharmacokinetic and pharmacodynamic properties of rapid-acting insulin analogs when given as a bolus by subcutaneous insulin infusion pump as typically encountered in the care of children with type 1 diabetes. The specific factors under investigation are: - the effects of puberty - type of insulin analog - site of catheter insertion - and age of catheter
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin Detemir
Insulin Glargine
Insulin Lispro
Insulin, Globin Zinc
Insulin, Long-Acting
Insulin, Short-Acting
Criteria
Inclusion Criteria:

1. Age 8-17 (inclusive), of whom 15 will be prepubertal and 60 pubertal;

2. Clinical diagnosis of T1D (based on clinical presentation, insulin dependence,and/or
history of ketosis;

3. Diagnosis of T1D for at least one year's duration;

4. On CSII therapy for at least three months;

5. HbA1c 6.5-8.0%, inclusive;

6. Body mass index < 95% for age and gender;

7. Meeting minimum weight requirement of at least 17.6 kg (for pre-pubertal subjects) or
34.6 kg (for pubertal subjects)

8. Ability to comprehend written and spoken English

Exclusion Criteria:

1. Any other medical disease aside from T1D or treated hypothyroidism

2. Receiving any other medication besides insulin or levothyroxine

3. Female subjects of reproductive potential who may be pregnant, breast feeding, or not
consistently utilizing barrier methods or abstinence as contraception

4. Inability to comprehend written and spoken English

5. Any other condition, which in the judgement of the investigators, would interfere with
the subject's or parents' ability to provide informed consent or the investigator's
ability to perform the study