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

This study has been completed.

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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

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

No publications provided

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

Keywords provided by Amylin Pharmaceuticals, Inc.:

Diabetes Mellitus, Type 2

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Islet Amyloid Polypeptide

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012