Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
1 other identifier
interventional
650
6 countries
44
Brief Summary
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Nov 2009
Typical duration for phase_3 type-2-diabetes-mellitus
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedAugust 11, 2010
August 1, 2010
1.9 years
October 16, 2009
August 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
52 weeks
Secondary Outcomes (1)
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
52 weeks
Study Arms (2)
dutogliptin/PHX1149T
EXPERIMENTALsitagliptin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Completion of all required visits of a qualifying Phase 3 core protocol
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
You may not qualify if:
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phenomixlead
- Forest Laboratoriescollaborator
Study Sites (44)
Phenomix Investigational Site 105
Montgomery, Alabama, United States
Phenomix Investigational Site 121
Tempe, Arizona, United States
Phenomix Investigational Site 137
Tempe, Arizona, United States
Phenomix Investigational Site 105
Anaheim, California, United States
Phenomix Investigational Site 103
Long Beach, California, United States
Phenomix Investigational Site 106
Los Angeles, California, United States
Phenomix Investigational Site 143
Coral Gables, Florida, United States
Phenomix Investigational Site 142
Hialeah, Florida, United States
Phenomix Investigational Site 133
Kissimmee, Florida, United States
Phenomix Investigational Site 101
Honolulu, Hawaii, United States
Phenomix Investigational Site 135
Chicago, Illinois, United States
Phenomix Investigational Site 124
Indianapolis, Indiana, United States
Phenomix Investigational Site 136
Brockton, Massachusetts, United States
Phenomix Investigational Site 138
Biloxi, Mississippi, United States
Phenomix Investigational Site 122
Las Vegas, Nevada, United States
Phenomix Investigational Site 140
Las Vegas, Nevada, United States
Phenomix Investigational Site 110
Trenton, New Jersey, United States
Phenomix Investigational Site 116
Albuquerque, New Mexico, United States
Phenomix Investigational Site 107
Winston-Salem, North Carolina, United States
Phenomix Investigational Site 112
Greenville, South Carolina, United States
Phenomix Investigational Site 102
Dallas, Texas, United States
Phenomix Investigational Site 104
San Antonio, Texas, United States
Phenomix Investigational Site 100
Kenosha, Wisconsin, United States
Phenomix Investigational Site 402
Buenos Aires, Argentina
Phenomix Investigational Site 408
Buenos Aires, Argentina
Phenomix Investigational Site 410
Mendoza, Argentina
Phenomix Investigational Site 208
Prague, Czechia
Phenomix Investigational Site 209
Praha 4 Chodov, Czechia
Phenomix Investigational Site 207
Uničov, Czechia
Phenomix Investigational Site 707
Shāstrinagar, Jaipur, India
Phenomix Investigational Site 701
Bangalore, Karnataka, India
Phenomix Investigational Site 705
Trivandrum, Kerala, India
Phenomix Investigational Site 706
Indore, Madhya Pradesh, India
Phenomix Investigational Site 711
Mumbai, Maharashtra, India
Phenomix Investigational Site 607
Arequipa, Peru
Phenomix Investigational Site 601
Ica, Peru
Phenomix Investigational Site 604
Lima, Peru
Phenomix Investigational Site 610
Lima, Peru
Phenomix Investigational Site 300
Gdansk, Poland
Phenomix Investigational Site 309
Karkow, Poland
Phenomix Investigational Site 303
Katowice, Poland
Phenomix Investigational Site 306
Puławy, Poland
Phenomix Investigational Site 305
Warsaw, Poland
Phenomix Investigational Site 302
Wroclaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 20, 2009
Study Start
November 1, 2009
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
August 11, 2010
Record last verified: 2010-08