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

NCT ID: NCT00865592

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

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Type 2 Diabetes

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

dutogliptin 400 mg, once daily tablet

Intervention Type DRUG

Other Intervention Names

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PHX1149T PHX1149 dutogliptin tartrate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Phenomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Phenomix

Locations

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Norwalk, California, United States

Site Status

Orange, California, United States

Site Status

Santa Ana, California, United States

Site Status

Daytona Beach, Florida, United States

Site Status

Kissimmee, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Phenomix Investigational Site 663

Honolulu, Hawaii, United States

Site Status

Brockton, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Cincinnati, Ohio, United States

Site Status

El Paso, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Norfolk, Virginia, United States

Site Status

Phenomix Investigational Site 103

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 110

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 111

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 106

Caba, , Argentina

Site Status

Phenomix Investigational Site 112

Corrientes, , Argentina

Site Status

Phenomix Investigational Site 102

Paraná, , Argentina

Site Status

Bangalore, Karnataka, , India

Site Status

Chennai, Tamil Nadu, , India

Site Status

Gulbarga, Karnataka, , India

Site Status

Hyderabad, Andhara Pradesh, , India

Site Status

Mumbai, Maharashtra, , India

Site Status

Nagpur, Maharashtra, , India

Site Status

Nashik, Maharashtra, , India

Site Status

Navi Mumbai, Maharashtra, , India

Site Status

Pune, Maharashtra, , India

Site Status

Phenomix Investigational Site 403

Kuching, Sarawak, Malaysia

Site Status

Kelantan, , Malaysia

Site Status

Kuala Lumpur, , Malaysia

Site Status

Perak, , Malaysia

Site Status

Phenomix Investigational Site 404

Putrajaya, , Malaysia

Site Status

Sarawak, , Malaysia

Site Status

Phenomix Investigational Site 604

Arequipa, , Peru

Site Status

Phenomix Investigational Site 606

Lambayeque, , Peru

Site Status

Phenomix Investigational Site 600

Lima, , Peru

Site Status

Phenomix Investigational Site 601

Lima, , Peru

Site Status

Phenomix Investigational Site 602

Lima, , Peru

Site Status

Phenomix Investigational Site 609

Lima, , Peru

Site Status

Phenomix Investigational Site 703

Cebu City, , Philippines

Site Status

Manila, NCR, , Philippines

Site Status

Quezon City, NCR, , Philippines

Site Status

San Juan, NCR, , Philippines

Site Status

Phenomix Investigational Site 802

Brasov, , Romania

Site Status

Phenomix Investigational Site 806

Brasov, , Romania

Site Status

Phenomix Investigational Site 800

Bucharest, , Romania

Site Status

Phenomix Investigational Site 803

Bucharest, , Romania

Site Status

Phenomix Investigational Site 805

Bucharest, , Romania

Site Status

Phenomix Investigational Site 807

Bucharest, , Romania

Site Status

Phenomix Investigational Site 804

Galati, , Romania

Site Status

Phenomix Investigational Site 801

Ploieşti, , Romania

Site Status

Phenomix Investigational Site 808

Sibiu, , Romania

Site Status

Phenomix Investigational Site 551

Ivano-Frankivsk, , Ukraine

Site Status

Phenomix Investigational Site 550

Kharkiv, , Ukraine

Site Status

Phenomix Investigational Site 557

Kharkiv, , Ukraine

Site Status

Phenomix Investigational Site 564

Kharkiv, , Ukraine

Site Status

Phenomix Investigational Site 555

Kiev, , Ukraine

Site Status

Phenomix Investigational Site 556

Kiev, , Ukraine

Site Status

Phenomix Investigational Site 562

Kiev, , Ukraine

Site Status

Phenomix Investigational Site 563

Kiev, , Ukraine

Site Status

Phenomix Investigational Site 554

Kylv, , Ukraine

Site Status

Phenomix Investigational Site 565

Lutsk, , Ukraine

Site Status

Phenomix Investigational Site 553

Lviv, , Ukraine

Site Status

Phenomix Investigational Site 561

Poltava, , Ukraine

Site Status

Phenomix Investigational Site 560

Simferopol, , Ukraine

Site Status

Phenomix Investigational Site 559

Vinnitsa, , Ukraine

Site Status

Phenomix Investigational Site 552

Zaporzhzhia, , Ukraine

Site Status

Countries

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United States Argentina India Malaysia Peru Philippines Romania Ukraine

Other Identifiers

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PHX1149-PROT300E

Identifier Type: -

Identifier Source: org_study_id

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