Clinical trial NCT01101945: Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
DPP4 inhibitor
dutogliptin
PHX1149
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin

Primary outcomes:
measure: To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
timeFrame: 104 weeks
measure: To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
timeFrame: 208 weeks (U.S. only)
Secondary outcomes:
measure: To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Fullerton
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Kissimmee
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Gurnee
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Margate City
country: United States
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Warminster
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Cuidad Autonoma de Buenos Aires
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Lanus Este
country: Argentina
state: Buenos Aires
city: Moron
country: Argentina
state: Buenos Aires
city: Quilmes
country: Argentina
state: Buenos Aires
city: Corrientes
country: Argentina
city: Calgary
country: Canada
state: Alberta
city: Red Deer
country: Canada
state: Alberta
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Etobicoke
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Samia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Cornwall
country: Canada
state: Prince Edward Island
city: Mirabel
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Ellisbridge
country: India
state: Ahmedabad
city: Banjara Hills
country: India
state: Hyderabad
city: Punjagutta
country: India
state: Hyderabad
city: Pune
country: India
state: Maharashtra
city: Tardeo
country: India
state: Mumbai
city: Dhantoli
country: India
state: Nagpur
city: Chennai
country: India
state: Tamilnadu
city: Mexico City
country: Mexico
state: Distrito Federal
city: Guadalajara
country: Mexico
state: Jalisco
city: Morelia
country: Mexico
state: Michoacan
city: Monterrey N. L.
country: Mexico
state: Nuevo Leon
Study officials:
References: