Study of the Long-Term Safety of Pramlintide in Subjects with Type 1 Diabetes Mellitus
Study identifier:137-150E
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects with Type 1 Diabetes Mellitus Completing Protocol 137-150
Medical condition
Diabetes Mellitus, Type 1
Phase
Phase 3
Healthy volunteers
No
Study drug
pramlintide acetate
Sex
All
Actual Enrollment
190
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Nov 2002
Primary Completion Date: 01 Jun 2005
Study Completion Date: 01 Jun 2005
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
N/A
Inclusion and exclusion criteria
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No locations available
| 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. | - |
Contacts
Contact
AstraZeneca Clinical Study Information Center Clinical Study Information Center
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
