| Trial ID: | L6329 |
| Source ID: | NCT00254254
|
| Associated Drug: |
Exenatide - Exenatide - Placebo
|
| Title: |
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Exenatide - Exenatide - Placebo|DRUG: Exenatide - Placebo - Exenatide|DRUG: Placebo - Exenatide - Exenatide
|
| Outcome Measures: |
Primary: To assess the pharmacokinetics of exenatide, 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., Three day-long (8 hour) assessments over a 5-week period|To assess the pharmacodynamics of exenatide, 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., Three day-long (8 hour) assessments over a 5-week period|Number of adverse events, 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, Visit 2 through Visit 4 |
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE2
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-02
|
| Completion Date: |
2007-02
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-23
|
| Locations: |
Research Site, Little Rock, Arkansas, United States|Research Site, San Diego, California, United States|Research Site, Denver, Colorado, United States|Research Site, Louisville, Kentucky, United States|Research Site, San Antonio, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00254254
|
