Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202
1 other identifier
interventional
339
5 countries
55
Brief Summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Jul 2007
Longer than P75 for phase_2 type-2-diabetes-mellitus
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedAugust 11, 2010
August 1, 2010
2.5 years
April 8, 2010
August 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
104 weeks
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
208 weeks (U.S. only)
Secondary Outcomes (1)
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
104 weeks
Interventions
400 mg QD
Eligibility Criteria
You may qualify if:
- Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
- Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD
You may not qualify if:
- Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phenomixlead
Study Sites (55)
Unknown Facility
Fullerton, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Gurnee, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Kansas City, Missouri, United States
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Henderson, Nevada, United States
Unknown Facility
Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
Unknown Facility
Margate City, New Jersey, United States
Unknown Facility
Trenton, New Jersey, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Warminster, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina
Unknown Facility
La Plata, Buenos Aires, Argentina
Unknown Facility
Lanús Este, Buenos Aires, Argentina
Unknown Facility
Morón, Buenos Aires, Argentina
Unknown Facility
Quilmes, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Calgary, Alberta, Canada
Unknown Facility
Red Deer, Alberta, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Etobicoke, Ontario, Canada
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London, Ontario, Canada
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Samia, Ontario, Canada
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Toronto, Ontario, Canada
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Cornwall, Prince Edward Island, Canada
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Mirabel, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Ellisbridge, Ahmedabad, India
Unknown Facility
Banjara Hills, Hyderabad, India
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Punjagutta, Hyderabad, India
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Pune, Maharashtra, India
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Tardeo, Mumbai, India
Unknown Facility
Dhantoli, Nagpur, India
Unknown Facility
Chennai, Tamil Nadu, India
Unknown Facility
Guadalajara, Jalisco, Mexico
Unknown Facility
Mexico City, Mexico City, Mexico
Unknown Facility
Morelia, Michoacán, Mexico
Unknown Facility
Monterrey N. L., Nuevo León, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 12, 2010
Study Start
July 1, 2007
Primary Completion
January 1, 2010
Study Completion
March 1, 2010
Last Updated
August 11, 2010
Record last verified: 2010-08