Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
NCT ID: NCT00042458
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
296 participants
INTERVENTIONAL
2002-04-30
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL
Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Pramlintide Acetate (AC137)
Pramlintide acetate (AC137) 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. The strength of pramlintide injection is 0.6 mg/mL
Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Interventions
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Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Eligibility Criteria
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Inclusion Criteria
* Using multiple daily insulin injections
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Ana Ventures LLC
Mesa, Arizona, United States
Phoenix Endocrinology Clinic, Ltd.
Phoenix, Arizona, United States
East Bay Clinical Trial Center
Concord, California, United States
Valley Research
Fresno, California, United States
UCSD Diabetes Research Center
San Diego, California, United States
Diabetes Research Institute
San Mateo, California, United States
Sansum Medical Research Institute
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, United States
Medical Research Unlimited
Aventura, Florida, United States
Medical Research Unlimited
Aventura, Florida, United States
Internal Medicine Associates
Fort Myers, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Children's Clinic
Tallahassee, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
St. James Diabetes Center
Chicago Heights, Illinois, United States
St. James Diabetes Center
Chicago Heights, Illinois, United States
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
University of Maryland Joslin Diabetes Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States
Radiant Research
St Louis, Missouri, United States
Mercury Street Medical
Butte, Montana, United States
UNC Diabetes Care Center
Durham, North Carolina, United States
Ohio State Univ.-Division of Endocrinology, Diabetes
Columbus, Ohio, United States
Radiant Research
Portland, Oregon, United States
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
North Texas Clinical Research
Irving, Texas, United States
Private Practice
Lufkin, Texas, United States
Private Practice
Lufkin, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
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References
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Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.
Other Identifiers
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137-150
Identifier Type: -
Identifier Source: org_study_id
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