Status:
COMPLETED
Evaluation of Pharmacokinetics and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs
Lead Sponsor:
Yale University
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
8-17 years
Phase:
PHASE1
Brief 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 typ...
Detailed Description
The aim of this study is to evaluate the variations in pharmacokinetic (as determined by serum free insulin concentrations) and pharmacodynamic (as determined by the glucose infusion rate required to ...
Eligibility Criteria
Inclusion
- Age 8-17 (inclusive), of whom 15 will be prepubertal and 60 pubertal;
- Clinical diagnosis of T1D (based on clinical presentation, insulin dependence,and/or history of ketosis;
- Diagnosis of T1D for at least one year's duration;
- On CSII therapy for at least three months;
- HbA1c 6.5-8.0%, inclusive;
- Body mass index \< 95% for age and gender;
- Meeting minimum weight requirement of at least 17.6 kg (for pre-pubertal subjects) or 34.6 kg (for pubertal subjects)
- Ability to comprehend written and spoken English
Exclusion
- Any other medical disease aside from T1D or treated hypothyroidism
- Receiving any other medication besides insulin or levothyroxine
- Female subjects of reproductive potential who may be pregnant, breast feeding, or not consistently utilizing barrier methods or abstinence as contraception
- Inability to comprehend written and spoken English
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00652288
Start Date
April 1 2007
End Date
September 1 2011
Last Update
September 1 2016
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