Evaluation of the Bioavailability of Pramlintide

This study has been completed.

First Received on July 30, 2002. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

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

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Diabetes Type 2

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

No publications provided

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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune 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