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

This study has been completed.

First Received: September 3, 2002 Last Updated: December 14, 2007 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	137-154
Study First Received:	September 3, 2002
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00044707 History of Changes
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:

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

Pramlintide
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009