Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
NCT ID: NCT00850239
Last Updated: 2010-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
700 participants
INTERVENTIONAL
2009-05-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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1
dutogliptin/PHX1149T
dutogliptin
400 mg
2
Plabeco
placebo
Interventions
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dutogliptin
400 mg
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 to 85 years, inclusive.
* Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
* Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
* HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Phenomix
INDUSTRY
Responsible Party
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Phenomix Corporation
Locations
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Phenomix Investigational Site 115
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 123
Chico, California, United States
Phenomix Investigational Site 134
Escondido, 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 119
Jacksonville, Florida, United States
Phenomix Investigational Site 133
Kissimmee, Florida, United States
Phenomix Investigational Site 141
Dunwoody, Georgia, 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 127
Indianapolis, Indiana, United States
Phenomix Investigational Site 136
Brockton, Massachusetts, United States
Phenomix Investigational Site 125
Kalamazoo, Michigan, 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 131
Brick, New Jersey, 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 130
Cincinnati, Ohio, United States
Phenomix Investigational Site 118
Cuyahoga Falls, Ohio, United States
Phenomix Investigational Site 112
Greenville, South Carolina, United States
Phenomix Investigational Site 102
Dallas, Texas, United States
Phenomix Investigational Site 139
Dallas, Texas, United States
Phenomix Investigational Site 126
El Paso, Texas, United States
Phenomix Investigational Site 104
San Antonio, Texas, United States
Phenomix Investigational Site 100
Kenosha, Wisconsin, United States
Phenomix Investigational Site 401
Buenos Aires, , Argentina
Phenomix Investigational Site 402
Buenos Aires, , Argentina
Phenomix Investigational Site 404
Buenos Aires, , Argentina
Phenomix Investigational Site 405
Buenos Aires, , Argentina
Phenomix Investigational Site 406
Buenos Aires, , Argentina
Phenomix Investigational Site 407
Buenos Aires, , Argentina
Phenomix Investigational Site 408
Buenos Aires, , Argentina
Phenomix Investigational Site 409
Buenos Aires, , Argentina
Phenomix Investigational Site 411
Buenos Aires, , Argentina
Phenomix Investigational Site 403
Corrientes, , Argentina
Phenomix Investigational Site 410
Mendoza, , Argentina
Phenomix Investigational Site 400
Rosario, , Argentina
Phenomix Investigational Site 502
Santiago, , Chile
Phenomix Investigational Site 504
Santiago, , Chile
Phenomix Investigational Site 505
Santiago, , Chile
Phenomix Investigational Site 500
Temuco, , Chile
Phenomix Investigational Site 501
Temuco, , Chile
Phenomix Investigational Site 209
Chodov, , Czechia
Phenomix Investigational Site 205
Havířov-Město, , Czechia
Phenomix Investigational Site 204
Liberec, , Czechia
Phenomix Investigational Site 202
Olomouc, , Czechia
Phenomix Investigational Site 206
Ostrava-Kunčice, , Czechia
Phenomix Investigational Site 208
Prague, , Czechia
Phenomix Investigational Site 203
Prostějov, , Czechia
Phenomix Investigational Site 207
Uničov, , Czechia
Phenomix Investigational Site 201
Valašské Klobouky, , Czechia
Phenomix Investigational Site 703
Hyderabad, Andhara Pradesh, India
Phenomix Investigational Site 704
Visakhapatanam, Andhra Pradesh, India
Phenomix Investigational Site 709
Gopālapuram, Chennai, India
Phenomix Investigational Site 707
Shāstrinagar, Jaipur, India
Phenomix Investigational Site 701
Bangalore, Karnataka, India
Phenomix Investigational Site 702
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 700
Nashik, Maharashtra, India
Phenomix Investigational Site 710
Navi Mumbai, Maharashtra, India
Phenomix Investigational Site 708
Chennai, , India
Phenomix Investigational Site 607
Arequipa, , Peru
Phenomix Investigational Site 601
Ica, , Peru
Phenomix Investigational Site 600
Lima, , Peru
Phenomix Investigational Site 603
Lima, , Peru
Phenomix Investigational Site 604
Lima, , Peru
Phenomix Investigational Site 608
Lima, , Peru
Phenomix Investigational Site 610
Lima, , Peru
Phenomix Investigational Site 605
Lima Cercado, , Peru
Phenomix Investigational Site 606
Piura, , Peru
Phenomix Investigational Site 602
Trujillo, , Peru
Phenomix Investigational Site 609
Wanchaq Cusco, , Peru
Phenomix Investigational Site 300
Gdansk, , Poland
Phenomix Investigational Site 301
Gdansk, , Poland
Phenomix Investigational Site 303
Katowice, , Poland
Phenomix Investigational Site 312
Katowice, , Poland
Phenomix Investigational Site 309
Krakow, , Poland
Phenomix Investigational Site 313
Krakow, , Poland
Phenomix Investigational Site 308
Lublin, , Poland
Phenomix Investigational Site 310
Poznan, , Poland
Phenomix Investigational Site 306
Puławy, , Poland
Phenomix Investigational Site 304
Szczecin, , Poland
Phenomix Investigational Site 305
Warsaw, , Poland
Phenomix Investigational Site 307
Warsaw, , Poland
Phenomix Investigational Site 311
Warsaw, , Poland
Phenomix Investigational Site 302
Wroclaw, , Poland
Countries
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Other Identifiers
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PHX1149-PROT302
Identifier Type: -
Identifier Source: org_study_id
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