A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Exenatide - Exenatide - Placebo (Drug); Exenatide - Placebo - Exenatide (Drug); Placebo - Exenatide - Exenatide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: To assess the pharmacokinetics of exenatideTo assess the pharmacodynamics of exenatide Number of adverse events
Eligibility
Minimum age: 10 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
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
Additional Information
Starting date: February 2006
Last updated: February 19, 2015
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