Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria: HbA1c value between 7.5-9% Using multiple daily insulin injections
Sites / Locations
- Ana Ventures LLC
- Phoenix Endocrinology Clinic, Ltd.
- East Bay Clinical Trial Center
- Valley Research
- UCSD Diabetes Research Center
- Diabetes Research Institute
- Sansum Medical Research Institute
- Diablo Clinical Research
- Barbara Davis Center for Childhood Diabetes
- MedStar Clinical Research Center
- Medical Research Unlimited
- Medical Research Unlimited
- Internal Medicine Associates
- Suncoast Clinical Research
- Children's Clinic
- Atlanta Diabetes Associates
- St. James Diabetes Center
- St. James Diabetes Center
- Indiana University Outpatient Clinical Research
- University of Maryland Joslin Diabetes Center
- Henry Ford Health System
- Grand Rapids Associated Interns
- Radiant Research
- Mercury Street Medical
- UNC Diabetes Care Center
- Ohio State Univ.-Division of Endocrinology, Diabetes
- Radiant Research
- Physicians for Clinical Research
- Vanderbilt University Medical Center
- North Texas Clinical Research
- Private Practice
- Private Practice
- Rainier Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Pramlintide Acetate (AC137)
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) 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