Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
10-16 years
Phase:
PHASE2
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 bioche...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00254254
Start Date
February 1 2006
End Date
February 1 2007
Last Update
February 23 2015
Active Locations (5)
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1
Research Site
Little Rock, Arkansas, United States
2
Research Site
San Diego, California, United States
3
Research Site
Denver, Colorado, United States
4
Research Site
Louisville, Kentucky, United States