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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254254
First received: November 14, 2005
Last updated: June 4, 2014
Last verified: June 2014

November 14, 2005
June 4, 2014
February 2006
February 2007   (final data collection date for primary outcome measure)
  • To assess the pharmacokinetics of exenatide [ Time Frame: Three day-long (8 hour) assessments over a 5-week period ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
  • - 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.
Complete list of historical versions of study NCT00254254 on ClinicalTrials.gov Archive Site
Not Provided
  • - 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.
Not Provided
Not Provided
 
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
10 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00254254
2993-124
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
June 2014

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