A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Study identifier:2993-124
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
Exenatide - Exenatide - Placebo, Exenatide - Placebo - Exenatide, Placebo - Exenatide - Exenatide
Sex
All
Actual Enrollment
13
Study type
Interventional
Age
10 Years - 16 Years
Date
Study Start Date: 01 Feb 2006
Primary Completion Date: 01 Feb 2007
Study Completion Date: 01 Feb 2007
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Co.
Inclusion and exclusion criteria
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| 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 |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
