A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

This study has been completed.

First Received: November 14, 2005 Last Updated: August 14, 2008 History of Changes

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00254254

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To evaluate the pharmacokinetics of exenatide in adolescent subjects with type 2 diabetes mellitus. [ Time Frame: single doses ]
To assess the safety and tolerability of exenatide in adolescent subjects with type 2 diabetes mellitus. [ Time Frame: single doses ]

Secondary Outcome Measures:

To compare the effects of exenatide on various pharmacodynamic measurements compared to placebo in adolescent subjects with type 2 diabetes mellitus. [ Time Frame: single doses ]

Estimated Enrollment:	12
Study Start Date:	December 2005
Study Completion Date:	August 2007

Intervention Details:

subcutaneous injection, 2.5mcg or 5mcg, single dose

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254254

Locations

United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
San Diego, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, Texas
Research Site
San Antonio, Texas, United States

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

Additional Information:

Link to study results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	2993-124
Study First Received:	November 14, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00254254 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
adolescents
exenatide
Amylin
Lilly

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Amylin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009