Clinical trial NCT00865592: Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Official title: An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Type 2 Diabetes
Keywords: diabetes
DPP4 inhibitor
dutogliptin
PHX1149
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2009-03-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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.

Detailed description: In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Eligibility criteria: Inclusion Criteria:

* Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria:

* Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
* 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
timeFrame: Two years
Secondary outcomes:
measure: To demonstrate maintenance or lowering of HbA1c
timeFrame: Two years
measure: To demonstrate maintenance or lowering of fasting blood glucose
timeFrame: Two years
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
facility: Phenomix Investigational Site 663
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: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 103
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 110
city: Buenos Aires
country: Argentina
facility: Phenomix Investigational Site 111
city: Caba
country: Argentina
facility: Phenomix Investigational Site 106
city: Corrientes
country: Argentina
facility: Phenomix Investigational Site 112
city: Paraná
country: Argentina
facility: Phenomix Investigational Site 102
city: Bangalore, Karnataka
country: India
city: Chennai, Tamil Nadu
country: India
city: Gulbarga, Karnataka
country: India
city: Hyderabad, Andhara Pradesh
country: India
city: Mumbai, Maharashtra
country: India
city: Nagpur, Maharashtra
country: India
city: Nashik, Maharashtra
country: India
city: Navi Mumbai, Maharashtra
country: India
city: Pune, Maharashtra
country: India
city: Kuching
country: Malaysia
facility: Phenomix Investigational Site 403
state: Sarawak
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Perak
country: Malaysia
city: Putrajaya
country: Malaysia
facility: Phenomix Investigational Site 404
city: Sarawak
country: Malaysia
city: Arequipa
country: Peru
facility: Phenomix Investigational Site 604
city: Lambayeque
country: Peru
facility: Phenomix Investigational Site 606
city: Lima
country: Peru
facility: Phenomix Investigational Site 600
city: Lima
country: Peru
facility: Phenomix Investigational Site 601
city: Lima
country: Peru
facility: Phenomix Investigational Site 602
city: Lima
country: Peru
facility: Phenomix Investigational Site 609
city: Cebu City
country: Philippines
facility: Phenomix Investigational Site 703
city: Manila, NCR
country: Philippines
city: Quezon City, NCR
country: Philippines
city: San Juan, NCR
country: Philippines
city: Brasov
country: Romania
facility: Phenomix Investigational Site 802
city: Brasov
country: Romania
facility: Phenomix Investigational Site 806
city: Bucharest
country: Romania
facility: Phenomix Investigational Site 800
city: Bucharest
country: Romania
facility: Phenomix Investigational Site 803
city: Bucharest
country: Romania
facility: Phenomix Investigational Site 805
city: Bucharest
country: Romania
facility: Phenomix Investigational Site 807
city: Galati
country: Romania
facility: Phenomix Investigational Site 804
city: Ploieşti
country: Romania
facility: Phenomix Investigational Site 801
city: Sibiu
country: Romania
facility: Phenomix Investigational Site 808
city: Ivano-Frankivsk
country: Ukraine
facility: Phenomix Investigational Site 551
city: Kharkiv
country: Ukraine
facility: Phenomix Investigational Site 557
city: Kharkiv
country: Ukraine
facility: Phenomix Investigational Site 564
city: Kharkov
country: Ukraine
facility: Phenomix Investigational Site 550
city: Kiev
country: Ukraine
facility: Phenomix Investigational Site 555
city: Kiev
country: Ukraine
facility: Phenomix Investigational Site 556
city: Kiev
country: Ukraine
facility: Phenomix Investigational Site 562
city: Kiev
country: Ukraine
facility: Phenomix Investigational Site 563
city: Kylv
country: Ukraine
facility: Phenomix Investigational Site 554
city: Lutsk
country: Ukraine
facility: Phenomix Investigational Site 565
city: Lviv
country: Ukraine
facility: Phenomix Investigational Site 553
city: Poltava
country: Ukraine
facility: Phenomix Investigational Site 561
city: Simferopol
country: Ukraine
facility: Phenomix Investigational Site 560
city: Vinnitsa
country: Ukraine
facility: Phenomix Investigational Site 559
city: Zaporzhzhia
country: Ukraine
facility: Phenomix Investigational Site 552
Study officials:
References: