DRUG
Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
Status
Completed
Phase
Phase 3
Enrollment
296
Locations
33
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Timeline
From registration to results.
First posted
Aug 1, 2002
Study start
Apr 2002
Primary completion
Mar 2003
Study completion
Mar 2003
Results posted
Not reported
Registry updated
Sep 23, 2015
Outcomes
What the study measures.
Primary outcomes
- 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.
Time frame · 29 Weeks
Secondary outcomes
- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
Time frame · 29 Weeks
- To examine the pattern of daily insulin use over the course of the study.
Time frame · 29 Weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * HbA1c value between 7.5-9% * Using multiple daily insulin injections
Study locations
33 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
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Related PeptideStat pages
Put the record in context.
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