Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

This study has been completed.

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00044707

Purpose

This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: Pramlintide acetate	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study

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

Estimated Enrollment:	24
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus treated with diet and/or oral agents
HbA1c 6.5-11.0

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044707

Locations

United States, Florida
ICSL-Clinical Studies
Fort Lauderdale, Florida, United States, 33301

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

More Information

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

Study ID Numbers:	137-154
Study First Received:	September 3, 2002
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00044707
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

Diabetes Mellitus, Type 2

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Pramlintide
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009