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
1 other identifier
interventional
13
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Feb 2006
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 16, 2005
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFebruary 23, 2015
January 1, 2015
1 year
November 14, 2005
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
Sequence 1
EXPERIMENTALExenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
Sequence 2
EXPERIMENTALExenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
Sequence 3
EXPERIMENTALPlacebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (5)
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
Related Publications (1)
Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.
PMID: 19446153DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 16, 2005
Study Start
February 1, 2006
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
February 23, 2015
Record last verified: 2015-01