Evaluation of Dose-Titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00042458

Purpose

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

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.:

Primary Outcome Measures:

- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.

Secondary Outcome Measures:

- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
- To examine the pattern of daily insulin use over the course of the study.

Study Start Date:

April 2002

Eligibility

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

Criteria

Inclusion Criteria:

HbA1c value between 7.5-9%
Using multiple daily insulin injections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042458

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Locations

United States, Arizona
Ana Ventures LLC
Mesa, Arizona, United States, 85204
Phoenix Endocrinology Clinic, Ltd.
Phoenix, Arizona, United States, 85006
United States, California
Valley Research
Fresno, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Sansum Medical Research Institute
Santa Barbara, California, United States
East Bay Clinical Trial Center
Concord, California, United States
UCSD Diabetes Research Center
San Diego, California, United States
Diabetes Research Institute
San Mateo, California, United States
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
United States, District of Columbia
MedStar Clinical Research Center
Washington, District of Columbia, United States
United States, Florida
Internal Medicine Associates
Ft. Myers, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Children's Clinic
Tallahassee, Florida, United States
Medical Research Unlimited
Aventura, Florida, United States
Medical Research Unlimited
Aventura, Florida, United States, 33180
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States
United States, Illinois
St. James Diabetes Center
Chicago Heights, Illinois, United States
St. James Diabetes Center
Chicago Heights, Illinois, United States, 60411
United States, Indiana
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
United States, Maryland
University of Maryland Joslin Diabetes Center
Baltimore, Maryland, United States, 21012
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
United States, Montana
Mercury Street Medical
Butte, Montana, United States
United States, North Carolina
UNC Diabetes Care Center
Durham, North Carolina, United States, 27713
United States, Ohio
Ohio State Univ.-Division of Endocrinology, Diabetes
Columbus, Ohio, United States, 43210
United States, Oregon
Radiant Research
Portland, Oregon, United States
United States, Pennsylvania
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
North Texas Clinical Research
Irving, Texas, United States
Private Practice
Lufkin, Texas, United States
Private Practice
Lufkin, Texas, United States, 75904
United States, Washington
Rainier Clinical Research Center
Renton, Washington, 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:	137-150
Study First Received:	July 30, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00042458 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
Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009