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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00254254
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 14, 2005
First Posted Date  ICMJE November 16, 2005
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • To assess the pharmacokinetics of exenatide [ Time Frame: Three day-long (8 hour) assessments over a 5-week period ]
    To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
  • To assess the pharmacodynamics of exenatide [ Time Frame: Three day-long (8 hour) assessments over a 5-week period ]
    To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
  • Number of adverse events [ Time Frame: Visit 2 through Visit 4 ]
    Adverse events will be assessed at all visits after the Screening Visit [Visit 2 (first time subject is dosed) through Visit 4 (study termination)]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • - To evaluate the pharmacokinetics of exenatide in adolescent subjects with type 2 diabetes mellitus.
  • - To assess the safety and tolerability of exenatide in adolescent subjects with type 2 diabetes mellitus.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • - To compare the effects of exenatide on the following endpoints compared to placebo in adolescent subjects with type 2 diabetes:
  • * Postprandial plasma glucose concentrations.
  • * Postprandial serum insulin concentrations.
  • * Postprandial plasma glucagon concentrations.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Brief Summary This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Exenatide - Exenatide - Placebo
    Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.
    Other Name: Byetta
  • Drug: Exenatide - Placebo - Exenatide
    Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
    Other Name: Byetta
  • Drug: Placebo - Exenatide - Exenatide
    Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
    Other Name: Byetta
Study Arms  ICMJE
  • Experimental: Sequence 1
    Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
    Intervention: Drug: Exenatide - Exenatide - Placebo
  • Experimental: Sequence 2
    Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
    Intervention: Drug: Exenatide - Placebo - Exenatide
  • Experimental: Sequence 3
    Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
    Intervention: Drug: Placebo - Exenatide - Exenatide
Publications * Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
13
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
12
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
  • Has HbA1c 6.0% to 11.0%, inclusive, at screening.
  • Has a body weight of >= 50 kg at screening.

Exclusion Criteria:

  • Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
  • Currently participates in any other interventional study.
  • Is currently treated with any of the following excluded medications:

    • Sulfonylurea chlorpropamide
    • Thiazolidinedione within 3 months of screening.
    • Αlpha glucosidase inhibitor within 3 months of screening.
    • Meglitinide within 3 months of screening.
    • Insulin within 3 months of screening.
    • Pramlintide within 3 months of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254254
Other Study ID Numbers  ICMJE 2993-124
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
PRS Account AstraZeneca
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP