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

NCT00652288 | Completed Phase 1

• 2 other identifiers: 403026582JDRF Hypoglycemia Grant
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Type I Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Maximum Glucose Infusion Rate (GIR) to maintain euglycemia

  Six hour observation period

Secondary Outcomes (1)

• Time to Maximum Glucose Infusion Rate

  Six Hour Observation period

Study Arms (4)

Catheter day 4

ACTIVE COMPARATOR

Adolescents with type 1 diabetes with catheters day #4

Drug: Insulin analogs (Lispro and Aspart)

Catheter day 1

ACTIVE COMPARATOR

Adolescents with type 1 diabetes with catheter day #1

Drug: Insulin analogs (Lispro and Aspart)

Aspart and Detemir

ACTIVE COMPARATOR

Adolescents with type 1 diabetes

Drug: Insulin analogs (Aspart and Detemir)

Lispro and Glargine

ACTIVE COMPARATOR

Adolescents with type 1 diabetes

Drug: Insulin analogs (Lispro and Glargine)

Interventions

Insulin analogs (Lispro and Aspart) DRUG

Insulin bolus given through insulin pump

Also known as: Humalog, Novolog

Catheter day 1; Catheter day 4

Insulin analogs (Aspart and Detemir) DRUG

Drugs given separately

Aspart and Detemir

Insulin analogs (Lispro and Glargine) DRUG

Drugs given separately

Lispro and Glargine

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Related Publications (4)

• Cengiz E, Swan KL, Tamborlane WV, Sherr JL, Martin M, Weinzimer SA. The alteration of aspart insulin pharmacodynamics when mixed with detemir insulin. Diabetes Care. 2012 Apr;35(4):690-2. doi: 10.2337/dc11-0732. Epub 2012 Feb 28.

  PMID: 22374642 RESULT

• Cengiz E, Tamborlane WV, Martin-Fredericksen M, Dziura J, Weinzimer SA. Early pharmacokinetic and pharmacodynamic effects of mixing lispro with glargine insulin: results of glucose clamp studies in youth with type 1 diabetes. Diabetes Care. 2010 May;33(5):1009-12. doi: 10.2337/dc09-2118. Epub 2010 Feb 11.

  PMID: 20150302 RESULT

• Swan KL, Dziura JD, Steil GM, Voskanyan GR, Sikes KA, Steffen AT, Martin ML, Tamborlane WV, Weinzimer SA. Effect of age of infusion site and type of rapid-acting analog on pharmacodynamic parameters of insulin boluses in youth with type 1 diabetes receiving insulin pump therapy. Diabetes Care. 2009 Feb;32(2):240-4. doi: 10.2337/dc08-0595. Epub 2008 Nov 18.

  PMID: 19017777 RESULT

• Swan KL, Weinzimer SA, Dziura JD, Steil GM, Voskanyan GR, Steffen AT, Martin ML, Tamborlane WV. Effect of puberty on the pharmacodynamic and pharmacokinetic properties of insulin pump therapy in youth with type 1 diabetes. Diabetes Care. 2008 Jan;31(1):44-6. doi: 10.2337/dc07-0737. Epub 2007 Oct 1. No abstract available.

  PMID: 17909083 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro; Insulin Aspart; Insulin Detemir; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Stuart A Weinzimer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Eda Cengiz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 3, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 1, 2016

Record last verified: 2016-08