Evaluation of the Bioavailability of Pramlintide

This study has been completed.

First Received: July 30, 2002 Last Updated: November 5, 2007 History of Changes

Sponsor:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00042471

Purpose

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Drug: Pramlintide acetate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Bio-availability Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

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

Study Start Date:

June 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HbA1c value between 6-12%
BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2
Consistent insulin regimen for 2 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042471

Locations

United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States

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:	137-153
Study First Received:	July 30, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00042471 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
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 November 27, 2009