Clinical trial NCT00998686: Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Official title: 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
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: 2009-10-20
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Completion of all required visits of a qualifying Phase 3 core protocol
* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria:

* 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

Primary outcomes:
measure: To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
timeFrame: 52 weeks
Secondary outcomes:
measure: To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Phenomix Investigational Site 105
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: 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: Kissimmee
country: United States
facility: Phenomix Investigational Site 133
state: Florida
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: Brockton
country: United States
facility: Phenomix Investigational Site 136
state: Massachusetts
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: 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: 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: 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 402
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 408
city: Mendoza
country: Argentina
facility: Phenomix Investigational Site 410
city: Praha 10
country: Czech Republic
facility: Phenomix Investigational Site 208
city: Praha 4 Chodov
country: Czech Republic
facility: Phenomix Investigational Site 209
city: Unicov
country: Czech Republic
facility: Phenomix Investigational Site 207
city: Shastrinagar
country: India
facility: Phenomix Investigational Site 707
state: Jaipur
city: Bangalore
country: India
facility: Phenomix Investigational Site 701
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: Mumbai
country: India
facility: Phenomix Investigational Site 711
state: Maharashtra
city: Arequipa
country: Peru
facility: Phenomix Investigational Site 607
city: Ica
country: Peru
facility: Phenomix Investigational Site 601
city: Lima
country: Peru
facility: Phenomix Investigational Site 604
city: Lima
country: Peru
facility: Phenomix Investigational Site 610
city: Gdansk
country: Poland
facility: Phenomix Investigational Site 300
city: Karkow
country: Poland
facility: Phenomix Investigational Site 309
city: Katowice
country: Poland
facility: Phenomix Investigational Site 303
city: Pulawy
country: Poland
facility: Phenomix Investigational Site 306
city: Warszawa
country: Poland
facility: Phenomix Investigational Site 305
city: Wroclaw
country: Poland
facility: Phenomix Investigational Site 302
Study officials:
References: