Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Placebo
- Registration Number
- NCT00042458
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
- HbA1c value between 7.5-9%
- Using multiple daily insulin injections
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo 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 Pramlintide Acetate (AC137) Pramlintide acetate 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
- Primary Outcome Measures
Name Time Method - 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. 29 Weeks
- Secondary Outcome Measures
Name Time Method - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. 29 Weeks - To examine the pattern of daily insulin use over the course of the study. 29 Weeks
Trial Locations
- Locations (29)
Grand Rapids Associated Interns
🇺🇸Grand Rapids, Michigan, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Private Practice
🇺🇸Lufkin, Texas, United States
St. James Diabetes Center
🇺🇸Chicago Heights, Illinois, United States
MedStar Clinical Research Center
🇺🇸Washington, District of Columbia, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
North Texas Clinical Research
🇺🇸Irving, Texas, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Internal Medicine Associates
🇺🇸Fort Myers, Florida, United States
Ana Ventures LLC
🇺🇸Mesa, Arizona, United States
East Bay Clinical Trial Center
🇺🇸Concord, California, United States
Medical Research Unlimited
🇺🇸Aventura, Florida, United States
Children's Clinic
🇺🇸Tallahassee, Florida, United States
Indiana University Outpatient Clinical Research
🇺🇸Indianapolis, Indiana, United States
Phoenix Endocrinology Clinic, Ltd.
🇺🇸Phoenix, Arizona, United States
Valley Research
🇺🇸Fresno, California, United States
UCSD Diabetes Research Center
🇺🇸San Diego, California, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
UNC Diabetes Care Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Diabetes Research Institute
🇺🇸San Mateo, California, United States
Sansum Medical Research Institute
🇺🇸Santa Barbara, California, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
University of Maryland Joslin Diabetes Center
🇺🇸Baltimore, Maryland, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Ohio State Univ.-Division of Endocrinology, Diabetes
🇺🇸Columbus, Ohio, United States
Physicians for Clinical Research
🇺🇸Camp Hill, Pennsylvania, United States
Radiant Research
🇺🇸Portland, Oregon, United States