Evaluation of Pharmacokinetics and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs
Condition: Diabetes Mellitus, Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

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
    

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 maintain euglycemia during a euglycemic clamp) properties of the 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 we
      will investigate are the effects of puberty (pre- vs. pubertal), type of insulin analog
      (lispro or aspart insulin), site of catheter insertion (gluteal vs. abdominal), and age of
      catheter (fresh insertion vs. three-day duration) Our hypotheses are that the peak (Imax) and
      area under the curve (IAUC) serum free insulin concentration, and the peak glucose infusion
      rate required to maintain euglycemia (GIRmax) and area under the curve (GIRAUC) will vary
      based on these conditions, in children given the same weight-based dose.

      We will also evaluate the pharmacokinetic and pharmacodynamic properties of Aspart and Lispro
      insulin when used in a basal-bolus regimen with insulin Detemir or Glargine, new basal
      insulin analogs, given as separate injections and when combined in a single injection in
      adolescent patients with Type 1 DM. We hypothesize that the peak (IMAX) and area under the
      curve (IAUC) serum insulin concentrations, and the peak glucose infusion rate required to
      maintain euglycemia (GIRMAX) and area under the curve (GIRAUC) of the Aspart/Lispro bolus,
      will be similar when the Aspart/Lispro is combined in the same syringe with the insulin
      Detemir/Glargine, compared to when the Aspart/Lispro and Detemir/Glargine are given as two
      separate injections.
    

Intervention name(s): Insulin analogs (Lispro and Aspart); Insulin analogs (Aspart and Detemir); Insulin analogs (Aspart and Detemir); Insulin analogs (Lispro and Glargine); Insulin analogs (Lispro and Glargine)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Insulin bolus given through insulin pump; Drugs given separately; Drugs given in the same injection; Drugs given separately; Drugs given in single injection
Other intervention name(s): Humalog, Novolog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro; Insulin Detemir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I Diabetes Mellitus