Clinical trial NCT00850239: Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
DPP4 inhibitor
dutogliptin
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2009-02-24
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
* 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:

* Type 1 diabetes mellitus

Primary outcomes:
measure: Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
timeFrame: 26 weeks
Secondary outcomes:
measure: Demonstrate safety and tolerability of dutogliptin
timeFrame: 26 weeks
measure: • Demonstrate changes in fasting plasma glucose
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Phenomix Investigational Site 115
state: Alabama
city: Tempe
country: United States
facility: Phenomix Investigational Site 121
state: Arizona
city: Tempe
country: United States
facility: Phenomix Investigational Site 137
state: Arizona
city: Anaheim
country: United States
facility: Phenomix Investigational Site 105
state: California
city: Chico
country: United States
facility: Phenomix Investigational Site 123
state: California
city: Escondido
country: United States
facility: Phenomix Investigational Site 134
state: California
city: Long Beach
country: United States
facility: Phenomix Investigational Site 103
state: California
city: Los Angeles
country: United States
facility: Phenomix Investigational Site 106
state: California
city: Coral Gables
country: United States
facility: Phenomix Investigational Site 143
state: Florida
city: Hialeah
country: United States
facility: Phenomix Investigational Site 142
state: Florida
city: Jacksonville
country: United States
facility: Phenomix Investigational Site 119
state: Florida
city: Kissimmee
country: United States
facility: Phenomix Investigational Site 133
state: Florida
city: Dunwoody
country: United States
facility: Phenomix Investigational Site 141
state: Georgia
city: Honolulu
country: United States
facility: Phenomix Investigational Site 101
state: Hawaii
city: Chicago
country: United States
facility: Phenomix Investigational Site 135
state: Illinois
city: Indianapolis
country: United States
facility: Phenomix Investigational Site 124
state: Indiana
city: Indianapolis
country: United States
facility: Phenomix Investigational Site 127
state: Indiana
city: Brockton
country: United States
facility: Phenomix Investigational Site 136
state: Massachusetts
city: Kalamazoo
country: United States
facility: Phenomix Investigational Site 125
state: Michigan
city: Biloxi
country: United States
facility: Phenomix Investigational Site 138
state: Mississippi
city: Las Vegas
country: United States
facility: Phenomix Investigational Site 122
state: Nevada
city: Las Vegas
country: United States
facility: Phenomix Investigational Site 140
state: Nevada
city: Brick
country: United States
facility: Phenomix Investigational Site 131
state: New Jersey
city: Trenton
country: United States
facility: Phenomix Investigational Site 110
state: New Jersey
city: Albuquerque
country: United States
facility: Phenomix Investigational Site 116
state: New Mexico
city: Winston-Salem
country: United States
facility: Phenomix Investigational Site 107
state: North Carolina
city: Cincinnati
country: United States
facility: Phenomix Investigational Site 130
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Phenomix Investigational Site 118
state: Ohio
city: Greenville
country: United States
facility: Phenomix Investigational Site 112
state: South Carolina
city: Dallas
country: United States
facility: Phenomix Investigational Site 102
state: Texas
city: Dallas
country: United States
facility: Phenomix Investigational Site 139
state: Texas
city: El Paso
country: United States
facility: Phenomix Investigational Site 126
state: Texas
city: San Antonio
country: United States
facility: Phenomix Investigational Site 104
state: Texas
city: Kenosha
country: United States
facility: Phenomix Investigational Site 100
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 401
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 402
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 404
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 405
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 406
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 407
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 408
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 409
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 411
city: Corrientes
country: Argentina
facility: Phenomix Investigational Site 403
city: Mendoza
country: Argentina
facility: Phenomix Investigational Site 410
city: Rosario
country: Argentina
facility: Phenomix Investigational Site 400
city: Santiago
country: Chile
facility: Phenomix Investigational Site 502
city: Santiago
country: Chile
facility: Phenomix Investigational Site 504
city: Santiago
country: Chile
facility: Phenomix Investigational Site 505
city: Temuco
country: Chile
facility: Phenomix Investigational Site 500
city: Temuco
country: Chile
facility: Phenomix Investigational Site 501
city: Chodov
country: Czech Republic
facility: Phenomix Investigational Site 209
city: Havířov-Město
country: Czech Republic
facility: Phenomix Investigational Site 205
city: Liberec
country: Czech Republic
facility: Phenomix Investigational Site 204
city: Olomouc
country: Czech Republic
facility: Phenomix Investigational Site 202
city: Ostrava Kunčice
country: Czech Republic
facility: Phenomix Investigational Site 206
city: Praha
country: Czech Republic
facility: Phenomix Investigational Site 208
city: Prostějov
country: Czech Republic
facility: Phenomix Investigational Site 203
city: Uničov
country: Czech Republic
facility: Phenomix Investigational Site 207
city: Valašské Klobouky
country: Czech Republic
facility: Phenomix Investigational Site 201
city: Hyderabad
country: India
facility: Phenomix Investigational Site 703
state: Andhara Pradesh
city: Visakhapatanam
country: India
facility: Phenomix Investigational Site 704
state: Andhra Pradesh
city: Gopalapuram
country: India
facility: Phenomix Investigational Site 709
state: Chennai
city: Shastrinagar
country: India
facility: Phenomix Investigational Site 707
state: Jaipur
city: Bangalore
country: India
facility: Phenomix Investigational Site 701
state: Karnataka
city: Bangalore
country: India
facility: Phenomix Investigational Site 702
state: Karnataka
city: Trivandrum
country: India
facility: Phenomix Investigational Site 705
state: Kerala
city: Indore
country: India
facility: Phenomix Investigational Site 706
state: Madhya Pradesh
city: Nashik
country: India
facility: Phenomix Investigational Site 700
state: Maharashtra
city: Navi Mumbai
country: India
facility: Phenomix Investigational Site 710
state: Maharashtra
city: Mumbai
country: India
facility: Phenomix Investigational Site 711
state: Maharastra
city: Chennai
country: India
facility: Phenomix Investigational Site 708
city: Arequipa
country: Peru
facility: Phenomix Investigational Site 607
city: Cercado de Lima
country: Peru
facility: Phenomix Investigational Site 605
city: Ica
country: Peru
facility: Phenomix Investigational Site 601
city: Lima
country: Peru
facility: Phenomix Investigational Site 600
city: Lima
country: Peru
facility: Phenomix Investigational Site 603
city: Lima
country: Peru
facility: Phenomix Investigational Site 604
city: Lima
country: Peru
facility: Phenomix Investigational Site 608
city: Lima
country: Peru
facility: Phenomix Investigational Site 610
city: Piura
country: Peru
facility: Phenomix Investigational Site 606
city: Trujillo
country: Peru
facility: Phenomix Investigational Site 602
city: Wanchaq Cusco
country: Peru
facility: Phenomix Investigational Site 609
city: Gdańsk
country: Poland
facility: Phenomix Investigational Site 300
city: Gdańsk
country: Poland
facility: Phenomix Investigational Site 301
city: Katowice
country: Poland
facility: Phenomix Investigational Site 303
city: Katowice
country: Poland
facility: Phenomix Investigational Site 312
city: Kraków
country: Poland
facility: Phenomix Investigational Site 309
city: Kraków
country: Poland
facility: Phenomix Investigational Site 313
city: Lublin
country: Poland
facility: Phenomix Investigational Site 308
city: Poznan
country: Poland
facility: Phenomix Investigational Site 310
city: Puławy
country: Poland
facility: Phenomix Investigational Site 306
city: Szczecin
country: Poland
facility: Phenomix Investigational Site 304
city: Warszawa
country: Poland
facility: Phenomix Investigational Site 305
city: Warszawa
country: Poland
facility: Phenomix Investigational Site 307
city: Warszawa
country: Poland
facility: Phenomix Investigational Site 311
city: Wrocław
country: Poland
facility: Phenomix Investigational Site 302
Study officials:
References: