A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00254254
- Run by
- AstraZeneca
- People needed
- 13
- Starts
- 2006-02-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2015-02-23
Who can join
Age: 10 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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