Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

NCT ID: NCT00690638

Last Updated: 2010-04-13

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-04-30

Brief Summary

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

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

DOUBLE

Participants Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2

PHX1149T 200 mg

Group Type EXPERIMENTAL

PHX1149T

Intervention Type DRUG

200 mg

3

PHX1149T 400 mg

Group Type EXPERIMENTAL

PHX1149T

Intervention Type DRUG

400 mg

Interventions

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PHX1149T

200 mg

Intervention Type DRUG

PHX1149T

400 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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dutogliptin dutogliptin

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
* BMI 25 to 48 kg/m2, inclusive
* HbA1c 7.0% - 10.0%, inclusive
* Age 18 to 75 years, inclusive

Exclusion Criteria

* Currently on 3 or more oral antidiabetic drugs or insulin.
* Type 1 diabetes mellitus
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 Corporation

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

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Brockton, Massachusetts, United States

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St Louis, Missouri, United States

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Cincinnati, Ohio, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Caba, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Lanús, Buenos Aires, Argentina

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Paraná, Entre Ríos Province, Argentina

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Salta, Salta Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Corrientes, , Argentina

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Hyderabad, Andhara Pradesh, India

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Bangalore, Karnataka, India

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Kalaburagi, Karnataka, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Navi Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Chennai, Tamil Nadu, India

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Kelantan, , Malaysia

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Kuala Lumpur, , Malaysia

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Perak, , Malaysia

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Sarawak, , Malaysia

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Arequipa, Arequipa, Peru

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Chiclayo-Lambayeque, Chiclayo, Peru

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Lima Cercado, Lima region, Peru

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Lince, Lima region, Peru

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San Miguel, Lima region, Peru

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San Isisdro, Lima, Peru

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Manila, NCR, Philippines

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Quezon City, NCR, Philippines

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San Juan City, NCR, Philippines

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Cebu City, VII, Philippines

Site Status

Brasov, Brașov County, Romania

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Jud. Brasov, Brașov County, Romania

Site Status

Sector 1, Bucharest, Romania

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Sector 2, Bucharest, Romania

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Galati, Galați County, Romania

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Ploieşti, Ploiesti, Romania

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Sibiu, Sibiu County, Romania

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Ratchatavi, Bangkok, Thailand

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Muang, Changwat Khon Kaen, Thailand

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Simferopol, Crimean Autonomy Republic, Ukraine

Site Status

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

2A Postysheva Pr., Kharkov, Ukraine

Site Status

Kiev, Kyiv City, Ukraine

Site Status

Kyiv, Kyiv Oblast, Ukraine

Site Status

Lviv, Lviv Oblast, Ukraine

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Poltava, Poltava Oblast, Ukraine

Site Status

Vinnytsa, Vinnytsa, Ukraine

Site Status

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Site Status

Countries

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United States Argentina India Malaysia Peru Philippines Romania Thailand Ukraine

Other Identifiers

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EudraCT 2008-002614-22

Identifier Type: -

Identifier Source: secondary_id

PHX1149-PROT301

Identifier Type: -

Identifier Source: org_study_id

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