Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
Study identifier:137-155
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
Medical condition
Type 1 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
pramlintide acetate
Sex
All
Actual Enrollment
400
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2003
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 Mar 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 | Drug: pramlintide acetate Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial. |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
