Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus - Full Text View

Purpose

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus	Drug: pramlintide acetate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

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, LLC.:

Primary Outcome Measures:

To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus

Estimated Enrollment:	400
Study Start Date:	April 2003
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
The subject has a HbA1c of 7.0% to 11.0% at Screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108004

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Locations

United States, California
Research Site
Anaheim, California, United States
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Escondido, California, United States
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La Jolla, California, United States
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Los Gatos, California, United States
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San Francisco, California, United States
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Torrance, California, United States
United States, Connecticut
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New Britain, Connecticut, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Clearwater, Florida, United States
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Orlando, Florida, United States
United States, Georgia
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Columbus, Georgia, United States
United States, Hawaii
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Honolulu, Hawaii, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Indiana
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Indianapolis, Indiana, United States
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Vincennes, Indiana, United States
United States, Kansas
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Topeka, Kansas, United States
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Wichita, Kansas, United States
United States, Kentucky
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Lexington, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Michigan
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Bloomfield Hills, Michigan, United States
United States, Mississippi
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Tupelo, Mississippi, United States
United States, Nevada
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
United States, New Jersey
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Moorestown, New Jersey, United States
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Neptune, New Jersey, United States
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Roseland, New Jersey, United States
United States, New York
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New York, New York, United States
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Williston Park, New York, United States
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Yonkers, New York, United States
United States, North Carolina
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Greenville, North Carolina, United States
United States, Ohio
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Lakewood, Ohio, United States
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Westlake, Ohio, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
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Wilkes Barre, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
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Sumter, South Carolina, United States
United States, Tennessee
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
United States, Texas
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Arlington, Texas, United States
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Dallas, Texas, United States
United States, Washington
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Olympia, Washington, United States
United States, Wisconsin
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States

Sponsors and Collaborators

Amylin Pharmaceuticals, LLC.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, LLC.

More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9.

ClinicalTrials.gov Identifier:	NCT00108004 History of Changes
Other Study ID Numbers:	137-155
Study First Received:	April 12, 2005
Last Updated:	February 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:

Diabetes
Amylin
Symlin
pramlintide acetate

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 May 21, 2013