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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide - Exenatide - Placebo
Drug: Exenatide - Placebo - Exenatide
Drug: Placebo - Exenatide - Exenatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: February 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
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
Experimental: Sequence 2
Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
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
Experimental: Sequence 3
Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
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

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254254

Locations
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
San Diego, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00254254     History of Changes
Other Study ID Numbers: 2993-124
Study First Received: November 14, 2005
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes
adolescents
exenatide
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014