Clinical trial NCT00690638: Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: dutogliptin
PHX1149
DPP4 inhibitor
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2008-06-04
Enrollment: 480
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: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
* BMI 25 to 48 kg/m2, inclusive
* HbA1c 7.0% - 10.0%, inclusive
* Age 18 to 75 years, inclusive

Exclusion Criteria:

* Currently on 3 or more oral antidiabetic drugs or insulin.
* Type 1 diabetes mellitus

Primary outcomes:
measure: To demonstrate changes in HbA1c
timeFrame: Day 28 to Day 196
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
state: California
city: Orange
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Daytona Beach
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Brockton
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Caba
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Lanús
country: Argentina
state: Buenos Aires
city: Paraná
country: Argentina
state: Entre Ríos
city: Rosario
country: Argentina
state: Santa Fé
city: Corrientes
country: Argentina
city: Salta
country: Argentina
city: Hyderabad
country: India
state: Andhara Pradesh
city: Bangalore
country: India
state: Karnataka
city: Gulbarga
country: India
state: Karnataka
city: Mumbai
country: India
state: Maharashtra
city: Nagpur
country: India
state: Maharashtra
city: Nashik
country: India
state: Maharashtra
city: Navi Mumbai
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Chennai
country: India
state: Tamil Nadu
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Perak
country: Malaysia
city: Sarawak
country: Malaysia
city: Arequipa
country: Peru
state: Arequipa Region
city: Chiclayo-Lambayeque
country: Peru
state: Chiclayo
city: Cercado de Lima
country: Peru
state: Lima
city: Lince
country: Peru
state: Lima
city: San Isisdro
country: Peru
state: Lima
city: San Miguel
country: Peru
state: Lima
city: Manila
country: Philippines
state: NCR
city: Quezon City
country: Philippines
state: NCR
city: San Juan
country: Philippines
state: NCR
city: Cebu City
country: Philippines
state: VII
city: Jud. Brasov
country: Romania
state: Brasov
city: Sector 1
country: Romania
state: Bucharest
city: Sector 2
country: Romania
state: Bucharest
city: Brasov
country: Romania
city: Galati
country: Romania
city: Ploiesti
country: Romania
city: Sibiu
country: Romania
city: Ratchatavi
country: Thailand
state: Bangkok
city: Muang
country: Thailand
state: Khon Kaen
city: Simferopol
country: Ukraine
state: Crimean Autonomy Republic
city: 2A Postysheva Pr.
country: Ukraine
state: Kharkov
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsa
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
References: