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

April 12, 2010 updated by: Phenomix

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Corrientes, Argentina
      • Salta, Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina
      • La Plata, Buenos Aires, Argentina
      • Lanús, Buenos Aires, Argentina
    • Entre Ríos
      • Paraná, Entre Ríos, Argentina
    • Santa Fé
      • Rosario, Santa Fé, Argentina
  • India
    • Andhara Pradesh
      • Hyderabad, Andhara Pradesh, India
    • Karnataka
      • Bangalore, Karnataka, India
      • Gulbarga, Karnataka, India
    • Maharashtra
      • Mumbai, Maharashtra, India
      • Nagpur, Maharashtra, India
      • Nashik, Maharashtra, India
      • Navi Mumbai, Maharashtra, India
      • Pune, Maharashtra, India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
  • Malaysia
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Perak, Malaysia
      • Sarawak, Malaysia
  • Peru
    • Arequipa Region
      • Arequipa, Arequipa Region, Peru
    • Chiclayo
      • Chiclayo-Lambayeque, Chiclayo, Peru
    • Lima
      • Cercado de Lima, Lima, Peru
      • Lince, Lima, Peru
      • San Isisdro, Lima, Peru
      • San Miguel, Lima, Peru
  • Philippines
    • NCR
      • Manila, NCR, Philippines
      • Quezon City, NCR, Philippines
      • San Juan, NCR, Philippines
    • VII
      • Cebu City, VII, Philippines
  • Romania
      • Brasov, Romania
      • Galati, Romania
      • Ploiesti, Romania
      • Sibiu, Romania
    • Brasov
      • Jud. Brasov, Brasov, Romania
    • Bucharest
      • Sector 1, Bucharest, Romania
      • Sector 2, Bucharest, Romania
  • Thailand
    • Bangkok
      • Ratchatavi, Bangkok, Thailand
    • Khon Kaen
      • Muang, Khon Kaen, Thailand
  • Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Poltava, Ukraine
      • Vinnytsa, Ukraine
      • Zaporizhzhia, Ukraine
    • Crimean Autonomy Republic
      • Simferopol, Crimean Autonomy Republic, Ukraine
    • Kharkov
      • 2A Postysheva Pr., Kharkov, Ukraine
  • United States
    • California
      • Norwalk, California, United States
      • Orange, California, United States
      • Santa Ana, California, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Kissimmee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • El Paso, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Experimental: 2
PHX1149T 200 mg
Drug: PHX1149T
200 mg
Other Names:
  • dutogliptin
Drug: PHX1149T
400 mg
Other Names:
  • dutogliptin
Experimental: 3
PHX1149T 400 mg
Drug: PHX1149T
200 mg
Other Names:
  • dutogliptin
Drug: PHX1149T
400 mg
Other Names:
  • dutogliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate changes in HbA1c
Time Frame: Day 28 to Day 196
Day 28 to Day 196

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phenomix

Collaborators

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHX1149-PROT301
  • EudraCT 2008-002614-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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