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Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108004
Recruitment Status : Completed
First Posted : April 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: pramlintide acetate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pramlintide

Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection.

It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43-mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative

 Drug: pramlintide acetate
Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.


Outcome Measures
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Primary Outcome Measures :
  1. To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]
    To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.

  2. Understand management issues in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]
    To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108004


Locations
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United States, California
Research Site
Anaheim, California, United States
Research Site
Escondido, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Gatos, California, United States
Research Site
San Francisco, California, United States
Research Site
Torrance, California, United States
United States, Connecticut
Research Site
New Britain, Connecticut, United States
Research Site
Norwalk, Connecticut, United States
Research Site
Norwich, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Clearwater, Florida, United States
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Columbus, Georgia, United States
United States, Hawaii
Research Site
Honolulu, Hawaii, United States
United States, Idaho
Research Site
Idaho Falls, Idaho, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
Research Site
Vincennes, Indiana, United States
United States, Kansas
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Michigan
Research Site
Bloomfield Hills, Michigan, United States
United States, Mississippi
Research Site
Tupelo, Mississippi, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
United States, New Jersey
Research Site
Moorestown, New Jersey, United States
Research Site
Neptune, New Jersey, United States
Research Site
Roseland, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
Research Site
Williston Park, New York, United States
Research Site
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
Research Site
Westlake, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Wilkes Barre, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
Research Site
Sumter, South Carolina, United States
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Arlington, Texas, United States
Research Site
Dallas, Texas, United States
United States, Washington
Research Site
Olympia, Washington, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00108004    
Other Study ID Numbers: 137-155
First Posted: April 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by AstraZeneca:
Diabetes
Amylin
Symlin
pramlintide acetate
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Pramlintide
Hypoglycemic Agents
Physiological Effects of Drugs