Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

September 9, 2011 updated by: Forest Laboratories

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

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 (Actual)

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.
252

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

  • Belarus
      • Mogilev, Belarus, 212030
        • Forest Investigative Site 209
  • Germany
      • Dresden, Germany, 01099
        • Forest Investigative Site 401
      • Dresden, Germany, 01307
        • Forest Investigative Site 402
      • Mainz, Germany, 55116
        • Forest Investigative Site 403
  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Forest Investigative Site 614
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Forest Investigative Site 618
    • Karnal
      • Haryana, Karnal, India, 132001
        • Forest Investigative Site 620
    • Karnataka
      • Bangalore, Karnataka, India, 560003
        • Forest Investigative Site 607
      • Bangalore, Karnataka, India, 560010
        • Forest Investigative Site 606
      • Bangalore, Karnataka, India, 560043
        • Forest Investigative Site 602
      • Bangalore, Karnataka, India, 560092
        • Forest Investigative Site 604
      • Mangalore, Karnataka, India, 575003
        • Forest Investigative Site 601
    • Maharashtra
      • Nagpur, Maharashtra, India, 440012
        • Forest Investigative Site 616
      • Nasik, Maharashtra, India, 380015
        • Forest Investigative Site 617
      • Pune, Maharashtra, India, 411037
        • Forest Investigative Site 612
    • Tamil Nadu
      • Channi, Tamil Nadu, India, 600020
        • Forest Investigative Site 603
      • Chennai, Tamil Nadu, India, 600013
        • Forest Investigative Site 613
      • Vellore, Tamil Nadu, India, 632009
        • Forest Investigative Site 615
  • Lithuania
    • Lithunia
      • Kaunas, Lithunia, Lithuania, 48259
        • Forest Investigative Site 702
      • Kaunas, Lithunia, Lithuania, 49456
        • Forest Investigative Site 703
      • Klaipeda, Lithunia, Lithuania, 92288
        • Forest Investigative Site 704
      • Vilnius, Lithunia, Lithuania, 09112
        • Forest Investigative Site 705
  • Romania
      • Bacau, Romania, 600164
        • Forest Investigative Site 909
      • Bucuresti, Romania, 010584
        • Forest Investigative Site 906
      • Bucuresti, Romania, 020725
        • Forest Investigative Site 908
      • Satu Mare, Romania, 440055
        • Forest Investigative Site 903
      • Sibiu, Romania, 550245
        • Forest Investigative Site 901
      • Tg Mures, Romania, 540142
        • Forest Investigative Site 905 Romania
      • Timisoara, Romania, 300736
        • Forest Investigative Site 902
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Forest Investigative Site 064
      • Birmingham, Alabama, United States, 35235
        • Forest Investigative Site 020
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Forest Investigative Site 059
      • Litchfield, Arizona, United States, 85340
        • Forest Investigative Site 096
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 098
      • Scottsdale, Arizona, United States, 85254
        • Forest Investigative Site 044
      • Tucson, Arizona, United States, 85741
        • Forest Investigative Site 087
    • California
      • Anaheim, California, United States, 92801
        • Forest Investigative Site 061
      • Chula Vista, California, United States, 91911
        • Forest Investigative Site 041
      • Encinitas, California, United States, 92024
        • Forest Investigative Site 049
      • Greenbrae, California, United States, 94904
        • Forest Investigative Site 022
      • Harbor City, California, United States, 90710
        • Forest Investigative Site 047
      • Huntington Park, California, United States, 90255
        • Forest Investigative Site 010
      • Northridge, California, United States, 91325
        • Forest Investigative Site 111
      • Riverside, California, United States, 92506
        • Forest Investigative Site 031
      • Roseville, California, United States, 95661
        • Forest Investigative Site 091
      • Sacramento, California, United States, 95821
        • Forest Investigative Site 067
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 112
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site 011
      • West Hills, California, United States, 91307
        • Forest Investigative Site 063
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Forest Investigative Site 115
    • Florida
      • Clearwater, Florida, United States, 33765
        • Forest Investigative Site 073
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site 004
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site 052
      • Jacksonville, Florida, United States, 32205
        • Forest Investigative Site 062
      • Miami, Florida, United States, 33169
        • Forest Investigative Site 021
      • Miami, Florida, United States, 33186
        • Forest Investigative Site 122
      • Miami, Florida, United States, 33183
        • Forest Investigative Site 050
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 015
      • Sarasota, Florida, United States, 34239
        • Forest Investigative Site 018
      • St. Petersburg, Florida, United States, 33716
        • Forest Investigative Site 075
      • West Palm Beach, Florida, United States, 33401
        • Forest Investigative Site 026
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Forest Investigative Site 045
      • Augusta, Georgia, United States, 30909
        • Forest Investigative Site 079
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Forest Investigative Site 009
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Forest Investigative Site 60
      • Peoria, Illinois, United States, 61614
        • Forest Investigative Site 030
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Forest Investigative Site 100
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site 097
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Forest Investigative Site 053
      • Wichita, Kansas, United States, 67203
        • Forest Investigative Site 008
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Forest Investigative Site 078
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site 024
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Forest Investigative Site 034
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Forest Investigative Site 035
      • Oxon Hill, Maryland, United States, 20745
        • Forest Investigative Site 046
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Forest Investigative Site 118
      • Waltham, Massachusetts, United States, 02453
        • Forest Investigative Site 007
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Forest Investigative Site 002
      • St. Clair Shores, Michigan, United States, 48081
        • Forest Investigative Site 029
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Forest Investigative Site 054
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Forest Investigative Site 013
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 072
      • Las Vegas, Nevada, United States, 89117
        • Forest Investigative Site 065
    • New York
      • New Hyde Park, New York, United States, 11042
        • Forest Investigative Site 081
      • New York, New York, United States, 10019
        • Forest Investigative Site 016
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Forest Investigative Site 094
      • Charlotte, North Carolina, United States, 28209
        • Forest Investigative Site 051
      • Charlotte, North Carolina, United States, 28277
        • Forest Investigative Site 117
      • Lenoir, North Carolina, United States, 28645
        • Forest Investigative Site 058
      • Morehead City, North Carolina, United States, 28557
        • Forest Investigative Site 038
      • Salisbury, North Carolina, United States, 28144
        • Forest Investigative Site 040
    • Ohio
      • Akron, Ohio, United States, 44311
        • Forest Investigative Site 039
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site 023
      • Columbus, Ohio, United States, 43201
        • Forest Investigative Site 043
      • Dayton, Ohio, United States, 45406
        • Forest Investigative Site 057
      • Kettering, Ohio, United States, 45429
        • Forest Investigative Site 032
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Forest Investigative Site 149
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Forest Investigative Site 102
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site 005
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Forest Investigative Site 037
      • Philadelphia, Pennsylvania, United States, 19152
        • Forest Investigative Site 066
      • Tipton, Pennsylvania, United States, 16684
        • Forest Investigative Site 036
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site 103
      • Manning, South Carolina, United States, 29102
        • Forest Investigative Site 090
      • Pelzer, South Carolina, United States, 29669
        • Forest Investigative Site 033
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Forest Investigative Site 114
      • Chattanooga, Tennessee, United States, 37421
        • Forest Investigative Site 104
    • Texas
      • Arlington, Texas, United States, 76014
        • Forest Investigative Site 099
      • Corpus Christi, Texas, United States, 78404
        • Forest Investigative Site 056
      • Dallas, Texas, United States, 75235
        • Forest Investigative Site 017
      • Dallas, Texas, United States, 75251
        • Forest Investigative Site 124
      • Houston, Texas, United States, 77079
        • Forest Investigative Site 106
      • Irving, Texas, United States, 75039
        • Forest Investigative Site 014
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 109
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Forest Investigative Site 076
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site 028
    • Washington
      • Spokane, Washington, United States, 99207
        • Forest Investigative Site 092
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Forest Investigative Site 027

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 3 months prior to Screening (Visit 1)
  • BMI 20 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 85 years, inclusive

Exclusion Criteria:

  • Currently taking more than one oral hypoglycemic agent
  • 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

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.
Placebo Comparator: 1
placebo, oral tablet administered once daily on background of pioglitazone
Drug: Placebo
placebo, oral tablet administered once daily on background of pioglitazone
Experimental: 2
dutogliptin, oral tablet administered once daily on background of pioglitazone
Drug: Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone

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
Hemoglobin A1c Level (HbA1c)
Time Frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)
HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)

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
Fasting Plasma Glucose Level (FPG)
Time Frame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).
FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).

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.
Forest Laboratories

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.
Phenomix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kaity Posada, PharmD, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

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.
August 1, 2009

Primary Completion (Actual)

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.
August 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).
September 1, 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.
September 1, 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.
September 2, 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.
September 21, 2011

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.
September 9, 2011

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.
September 1, 2011

More Information

Terms related to this study

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.
  • DUT-MD-304

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.

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