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Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

NCT ID: NCT00998686

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

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dutogliptin/PHX1149T

Group Type EXPERIMENTAL

dutogliptin

Intervention Type DRUG

400 mg

sitagliptin

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

100 mg

Interventions

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dutogliptin

400 mg

Intervention Type DRUG

sitagliptin

100 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of all required visits of a qualifying Phase 3 core protocol
* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria

* 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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Phenomix Investigational Site 105

Montgomery, Alabama, United States

Site Status

Phenomix Investigational Site 121

Tempe, Arizona, United States

Site Status

Phenomix Investigational Site 137

Tempe, Arizona, United States

Site Status

Phenomix Investigational Site 105

Anaheim, California, United States

Site Status

Phenomix Investigational Site 103

Long Beach, California, United States

Site Status

Phenomix Investigational Site 106

Los Angeles, California, United States

Site Status

Phenomix Investigational Site 143

Coral Gables, Florida, United States

Site Status

Phenomix Investigational Site 142

Hialeah, Florida, United States

Site Status

Phenomix Investigational Site 133

Kissimmee, Florida, United States

Site Status

Phenomix Investigational Site 101

Honolulu, Hawaii, United States

Site Status

Phenomix Investigational Site 135

Chicago, Illinois, United States

Site Status

Phenomix Investigational Site 124

Indianapolis, Indiana, United States

Site Status

Phenomix Investigational Site 136

Brockton, Massachusetts, United States

Site Status

Phenomix Investigational Site 138

Biloxi, Mississippi, United States

Site Status

Phenomix Investigational Site 122

Las Vegas, Nevada, United States

Site Status

Phenomix Investigational Site 140

Las Vegas, Nevada, United States

Site Status

Phenomix Investigational Site 110

Trenton, New Jersey, United States

Site Status

Phenomix Investigational Site 116

Albuquerque, New Mexico, United States

Site Status

Phenomix Investigational Site 107

Winston-Salem, North Carolina, United States

Site Status

Phenomix Investigational Site 112

Greenville, South Carolina, United States

Site Status

Phenomix Investigational Site 102

Dallas, Texas, United States

Site Status

Phenomix Investigational Site 104

San Antonio, Texas, United States

Site Status

Phenomix Investigational Site 100

Kenosha, Wisconsin, United States

Site Status

Phenomix Investigational Site 402

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 408

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 410

Mendoza, , Argentina

Site Status

Phenomix Investigational Site 208

Prague, , Czechia

Site Status

Phenomix Investigational Site 209

Praha 4 Chodov, , Czechia

Site Status

Phenomix Investigational Site 207

Uničov, , Czechia

Site Status

Phenomix Investigational Site 707

Shāstrinagar, Jaipur, India

Site Status

Phenomix Investigational Site 701

Bangalore, Karnataka, India

Site Status

Phenomix Investigational Site 705

Trivandrum, Kerala, India

Site Status

Phenomix Investigational Site 706

Indore, Madhya Pradesh, India

Site Status

Phenomix Investigational Site 711

Mumbai, Maharashtra, India

Site Status

Phenomix Investigational Site 607

Arequipa, , Peru

Site Status

Phenomix Investigational Site 601

Ica, , Peru

Site Status

Phenomix Investigational Site 604

Lima, , Peru

Site Status

Phenomix Investigational Site 610

Lima, , Peru

Site Status

Phenomix Investigational Site 300

Gdansk, , Poland

Site Status

Phenomix Investigational Site 309

Karkow, , Poland

Site Status

Phenomix Investigational Site 303

Katowice, , Poland

Site Status

Phenomix Investigational Site 306

Puławy, , Poland

Site Status

Phenomix Investigational Site 305

Warsaw, , Poland

Site Status

Phenomix Investigational Site 302

Wroclaw, , Poland

Site Status

Countries

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United States Argentina Czechia India Peru Poland

Other Identifiers

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PHX1149-PROT402

Identifier Type: -

Identifier Source: org_study_id

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