Study identifier:137-150E
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects with Type 1 Diabetes Mellitus Completing Protocol 137-150
Diabetes Mellitus, Type 1
Phase 3
No
pramlintide acetate
All
190
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
N/A
This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.
Location
Location
Portland, OR, United States
Location
Tempe, AZ, United States
Location
Durham, NC, United States
Location
Aventura, FL, United States
Location
Atlanta, GA, United States
Location
Santa Barbara, CA, United States
Location
Concord, CA, United States
Location
Renton, WA, United States
Arms | Assigned Interventions |
---|---|
Active Comparator: Pramlintide Acetate Pramlintide acetate 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 concentration of pramlintide injection to be used in this study is 0.6 mg/mL. | Drug: pramlintide acetate Syringe vial and Pen-cartridge |
Placebo Comparator: Plaebo Placebo solution is the same sterile preserved formulation, without the active ingredient, pramlintide. | - |
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