Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01101945

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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dutogliptin

400 mg QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phenomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Phenomix Corporation

Locations

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Fullerton, California, United States

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Long Beach, California, United States

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Orange, California, United States

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San Diego, California, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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New Port Richey, Florida, United States

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Gurnee, Illinois, United States

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Wichita, Kansas, United States

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Kansas City, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Margate City, New Jersey, United States

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Trenton, New Jersey, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Warminster, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Lanús Este, Buenos Aires, Argentina

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Morón, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Corrientes, Corrientes Province, Argentina

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Samia, Ontario, Canada

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Toronto, Ontario, Canada

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Cornwall, Prince Edward Island, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Ellisbridge, Ahmedabad, India

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Banjara Hills, Hyderabad, India

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Punjagutta, Hyderabad, India

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Pune, Maharashtra, India

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Tardeo, Mumbai, India

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Dhantoli, Nagpur, India

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Chennai, Tamil Nadu, India

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Morelia, Michoacán, Mexico

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Monterrey N. L., Nuevo León, Mexico

Site Status

Countries

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United States Argentina Canada India Mexico

Other Identifiers

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PHX1149-PROT202E

Identifier Type: -

Identifier Source: org_study_id

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