Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exenatide - Exenatide - Placebo Drug: Exenatide - Placebo - Exenatide Drug: Placebo - Exenatide - Exenatide Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : February 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254254


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00254254    
Other Study ID Numbers: 2993-124
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: January 2015
Keywords provided by AstraZeneca:
diabetes
adolescents
exenatide
Amylin
Lilly
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists