Status:
TERMINATED
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Lead Sponsor:
MacroGenics
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
10-37 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).
Detailed Description
The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) includ...
Eligibility Criteria
Inclusion
- Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
- Provide written informed consent.
Exclusion
- None
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00870818
Start Date
February 1 2009
End Date
May 1 2011
Last Update
August 9 2023
Active Locations (1)
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1
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309