Evaluation of Pharmacokinetics and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs - Full Text View

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00652288

Purpose

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

Condition	Intervention
Diabetes Mellitus, Type I	Drug: Insulin analogs (Lispro and Aspart)

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII) and in MDI Basal-Bolus Therapy in Pediatric Subjects With Type 1 Diabetes (TID)

Further study details as provided by Yale University:

Primary Outcome Measures:

Maximum Glucose Infusion Rate (GIR) to maintain euglycemia [ Time Frame: Six hour observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Maximum Glucose Infusion Rate [ Time Frame: Six Hour Observation period ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	April 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Catheter day #4	Drug: Insulin analogs (Lispro and Aspart) Insulin bolus given through insulin pump
2: Active Comparator Catheter day #1	Drug: Insulin analogs (Lispro and Aspart) Insulin bolus given through insulin pump

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 insulin when it is used in a basal-bolus regimen with insulin Detemir, a new basal insulin analog, 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 concentration, and the peak glucose infusion rate required to maintain euglycemia (GIRMAX) and area under the curve (GIRAUC) of the Aspart bolus, will be similar when the Aspart is combined in the same syringe with the insulin Detemir, compared to when the Aspart and Detemir are given as two separate injections.

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652288

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Stuart A Weinzimer, MD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Stuart Weinzimer, MD )
Study ID Numbers:	403026582, JDRF Hypoglycemia Grant
Study First Received:	March 27, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00652288
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Type I Diabetes Mellitus

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009