Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

August 10, 2010 updated by: Phenomix

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 401
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 402
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 404
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 405
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 406
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 407
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 408
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 409
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 411
      • Corrientes, Argentina
        • Phenomix Investigational Site 403
      • Mendoza, Argentina
        • Phenomix Investigational Site 410
      • Rosario, Argentina
        • Phenomix Investigational Site 400
  • Chile
      • Santiago, Chile
        • Phenomix Investigational Site 502
      • Santiago, Chile
        • Phenomix Investigational Site 504
      • Santiago, Chile
        • Phenomix Investigational Site 505
      • Temuco, Chile
        • Phenomix Investigational Site 500
      • Temuco, Chile
        • Phenomix Investigational Site 501
  • Czech Republic
      • Chodov, Czech Republic
        • Phenomix Investigational Site 209
      • Havířov-Město, Czech Republic
        • Phenomix Investigational Site 205
      • Liberec, Czech Republic
        • Phenomix Investigational Site 204
      • Olomouc, Czech Republic
        • Phenomix Investigational Site 202
      • Ostrava Kunčice, Czech Republic
        • Phenomix Investigational Site 206
      • Praha, Czech Republic
        • Phenomix Investigational Site 208
      • Prostějov, Czech Republic
        • Phenomix Investigational Site 203
      • Uničov, Czech Republic
        • Phenomix Investigational Site 207
      • Valašské Klobouky, Czech Republic
        • Phenomix Investigational Site 201
  • India
      • Chennai, India
        • Phenomix Investigational Site 708
    • Andhara Pradesh
      • Hyderabad, Andhara Pradesh, India
        • Phenomix Investigational Site 703
    • Andhra Pradesh
      • Visakhapatanam, Andhra Pradesh, India
        • Phenomix Investigational Site 704
    • Chennai
      • Gopalapuram, Chennai, India
        • Phenomix Investigational Site 709
    • Jaipur
      • Shastrinagar, Jaipur, India
        • Phenomix Investigational Site 707
    • Karnataka
      • Bangalore, Karnataka, India
        • Phenomix Investigational Site 701
      • Bangalore, Karnataka, India
        • Phenomix Investigational Site 702
    • Kerala
      • Trivandrum, Kerala, India
        • Phenomix Investigational Site 705
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Phenomix Investigational Site 706
    • Maharashtra
      • Nashik, Maharashtra, India
        • Phenomix Investigational Site 700
      • Navi Mumbai, Maharashtra, India
        • Phenomix Investigational Site 710
    • Maharastra
      • Mumbai, Maharastra, India
        • Phenomix Investigational Site 711
  • Peru
      • Arequipa, Peru
        • Phenomix Investigational Site 607
      • Cercado de Lima, Peru
        • Phenomix Investigational Site 605
      • Ica, Peru
        • Phenomix Investigational Site 601
      • Lima, Peru
        • Phenomix Investigational Site 600
      • Lima, Peru
        • Phenomix Investigational Site 603
      • Lima, Peru
        • Phenomix Investigational Site 604
      • Lima, Peru
        • Phenomix Investigational Site 608
      • Lima, Peru
        • Phenomix Investigational Site 610
      • Piura, Peru
        • Phenomix Investigational Site 606
      • Trujillo, Peru
        • Phenomix Investigational Site 602
      • Wanchaq Cusco, Peru
        • Phenomix Investigational Site 609
  • Poland
      • Gdańsk, Poland
        • Phenomix Investigational Site 300
      • Gdańsk, Poland
        • Phenomix Investigational Site 301
      • Katowice, Poland
        • Phenomix Investigational Site 303
      • Katowice, Poland
        • Phenomix Investigational Site 312
      • Kraków, Poland
        • Phenomix Investigational Site 309
      • Kraków, Poland
        • Phenomix Investigational Site 313
      • Lublin, Poland
        • Phenomix Investigational Site 308
      • Poznan, Poland
        • Phenomix Investigational Site 310
      • Puławy, Poland
        • Phenomix Investigational Site 306
      • Szczecin, Poland
        • Phenomix Investigational Site 304
      • Warszawa, Poland
        • Phenomix Investigational Site 305
      • Warszawa, Poland
        • Phenomix Investigational Site 307
      • Warszawa, Poland
        • Phenomix Investigational Site 311
      • Wrocław, Poland
        • Phenomix Investigational Site 302
  • United States
    • Alabama
      • Montgomery, Alabama, United States
        • Phenomix Investigational Site 115
    • Arizona
      • Tempe, Arizona, United States
        • Phenomix Investigational Site 121
      • Tempe, Arizona, United States
        • Phenomix Investigational Site 137
    • California
      • Anaheim, California, United States
        • Phenomix Investigational Site 105
      • Chico, California, United States
        • Phenomix Investigational Site 123
      • Escondido, California, United States
        • Phenomix Investigational Site 134
      • Long Beach, California, United States
        • Phenomix Investigational Site 103
      • Los Angeles, California, United States
        • Phenomix Investigational Site 106
    • Florida
      • Coral Gables, Florida, United States
        • Phenomix Investigational Site 143
      • Hialeah, Florida, United States
        • Phenomix Investigational Site 142
      • Jacksonville, Florida, United States
        • Phenomix Investigational Site 119
      • Kissimmee, Florida, United States
        • Phenomix Investigational Site 133
    • Georgia
      • Dunwoody, Georgia, United States
        • Phenomix Investigational Site 141
    • Hawaii
      • Honolulu, Hawaii, United States
        • Phenomix Investigational Site 101
    • Illinois
      • Chicago, Illinois, United States
        • Phenomix Investigational Site 135
    • Indiana
      • Indianapolis, Indiana, United States
        • Phenomix Investigational Site 124
      • Indianapolis, Indiana, United States
        • Phenomix Investigational Site 127
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Phenomix Investigational Site 136
    • Michigan
      • Kalamazoo, Michigan, United States
        • Phenomix Investigational Site 125
    • Mississippi
      • Biloxi, Mississippi, United States
        • Phenomix Investigational Site 138
    • Nevada
      • Las Vegas, Nevada, United States
        • Phenomix Investigational Site 122
      • Las Vegas, Nevada, United States
        • Phenomix Investigational Site 140
    • New Jersey
      • Brick, New Jersey, United States
        • Phenomix Investigational Site 131
      • Trenton, New Jersey, United States
        • Phenomix Investigational Site 110
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Phenomix Investigational Site 116
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Phenomix Investigational Site 107
    • Ohio
      • Cincinnati, Ohio, United States
        • Phenomix Investigational Site 130
      • Cuyahoga Falls, Ohio, United States
        • Phenomix Investigational Site 118
    • South Carolina
      • Greenville, South Carolina, United States
        • Phenomix Investigational Site 112
    • Texas
      • Dallas, Texas, United States
        • Phenomix Investigational Site 102
      • Dallas, Texas, United States
        • Phenomix Investigational Site 139
      • El Paso, Texas, United States
        • Phenomix Investigational Site 126
      • San Antonio, Texas, United States
        • Phenomix Investigational Site 104
    • Wisconsin
      • Kenosha, Wisconsin, United States
        • Phenomix Investigational Site 100

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, diagnosed at least 4 months prior to Screening (Visit 1)
  • Age 18 to 85 years, inclusive.
  • Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
  • Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
  • HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)

Exclusion Criteria:

  • 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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
dutogliptin/PHX1149T
Drug: dutogliptin
400 mg
Other Names:
  • PHX1149T
Placebo Comparator: 2
Plabeco
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Demonstrate safety and tolerability of dutogliptin
Time Frame: 26 weeks
26 weeks
• Demonstrate changes in fasting plasma glucose
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phenomix

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHX1149-PROT302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings