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

NCT00652288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-09-01

No results posted yet for this study

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

Conditions

  • Diabetes Mellitus, Type I

Interventions

DRUG

Insulin analogs (Lispro and Aspart)

Insulin bolus given through insulin pump

DRUG

Insulin analogs (Aspart and Detemir)

Drugs given separately

DRUG

Insulin analogs (Aspart and Detemir)

Drugs given in the same injection

DRUG

Insulin analogs (Lispro and Glargine)

Drugs given separately

DRUG

Insulin analogs (Lispro and Glargine)

Drugs given in single injection

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Stuart A Weinzimer, MD · Yale University

  • Eda Cengiz, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652288 on ClinicalTrials.gov