Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dutogliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, DPP4 inhibitor, dutogliptin, PHX1149
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
Sites / Locations
Outcomes
Primary Outcome Measures
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Secondary Outcome Measures
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01101945
Brief Title
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
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Phenomix
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, DPP4 inhibitor, dutogliptin, PHX1149
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
339 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dutogliptin
Intervention Description
400 mg QD
Primary Outcome Measure Information:
Title
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time Frame
104 weeks
Title
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time Frame
208 weeks (U.S. only)
Secondary Outcome Measure Information:
Title
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
Time Frame
104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Fullerton
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Melbourne
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Margate City
State/Province
New Jersey
Country
United States
City
Trenton
State/Province
New Jersey
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Warminster
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Cuidad Autonoma de Buenos Aires
State/Province
Buenos Aires
Country
Argentina
City
La Plata
State/Province
Buenos Aires
Country
Argentina
City
Lanus Este
State/Province
Buenos Aires
Country
Argentina
City
Moron
State/Province
Buenos Aires
Country
Argentina
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
City
Corrientes
Country
Argentina
City
Calgary
State/Province
Alberta
Country
Canada
City
Red Deer
State/Province
Alberta
Country
Canada
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
City
Etobicoke
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Samia
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Cornwall
State/Province
Prince Edward Island
Country
Canada
City
Mirabel
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Ellisbridge
State/Province
Ahmedabad
Country
India
City
Banjara Hills
State/Province
Hyderabad
Country
India
City
Punjagutta
State/Province
Hyderabad
Country
India
City
Pune
State/Province
Maharashtra
Country
India
City
Tardeo
State/Province
Mumbai
Country
India
City
Dhantoli
State/Province
Nagpur
Country
India
City
Chennai
State/Province
Tamilnadu
Country
India
City
Mexico City
State/Province
Distrito Federal
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Morelia
State/Province
Michoacan
Country
Mexico
City
Monterrey N. L.
State/Province
Nuevo Leon
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
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