Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone (REDWOOD403)

September 14, 2011 updated by: Forest Laboratories

A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Forest Investigative Site 064
      • Birmingham, Alabama, United States, 35235
        • Forest Investigative Site 020
      • Muscle Shoals, Alabama, United States, 35661
        • Forest Investigative Site 025
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Forest Investigative Site 059
      • Gilbert, Arizona, United States, 85295
        • Forest Investigative Site 113
      • Goodyear, Arizona, United States, 85395
        • Forest Investigative Site 096
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site 080
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 098
      • Phoenix, Arizona, United States, 85023
        • Forest Investigative Site 133
      • 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
      • Anaheim, California, United States, 92804
        • Forest Investigative Site 152
      • 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
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site 070
      • 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
      • Sacramento, California, United States, 95816
        • Forest Investigative Site 140
      • San Mateo, California, United States, 94401
        • Forest Investigative Site 145
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 112
      • Tustin, California, United States, 92780
        • Forest Investigative Site 128
      • 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
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site 088
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Forest Investigative Site 156
      • Brandenton, Florida, United States, 34205
        • Forest Investigative Site 148
      • 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
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site 144
      • Hollywood, Florida, United States, 33021
        • Forest Investigative Site 129
      • Jacksonville, Florida, United States, 32205
        • Forest Investigative Site 062
      • Miami, Florida, United States, 33186
        • Forest Investigative Site 122
      • Miami, Florida, United States, 33136
        • Forest Investigative Site 161
      • Miami, Florida, United States, 33143
        • Forest Investigative Site 157
      • Miami, Florida, United States, 33175
        • Forest Investigative Site 154
      • Miami, Florida, United States, 33183
        • Forest Investigative Site 050
      • Miami Lakes, Florida, United States, 33014
        • Forest Investigative Site 125
      • New Port Richey, Florida, United States, 34652
        • Forest Investigative Site 069
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site 012
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 015
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site 131
      • Pembroke Pines, Florida, United States, 33028
        • Forest Investigative Site 127
      • Sarasota, Florida, United States, 34239
        • Forest Investigative Site 018
      • St Petersburg, Florida, United States, 33716
        • Forest Investigative Site 075
      • Tamarac, Florida, United States, 33319
        • Forest Investigative Site 138
      • 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
      • Decatur, Georgia, United States, 30035
        • Forest Investigative Site 077
      • Dunwoody, Georgia, United States, 30338
        • Forest Investigative Site 042
      • Roswell, Georgia, United States, 30076
        • Forest Investigative Site 084
      • Roswell, Georgia, United States, 30076
        • Forest Investigative Site 132
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Forest Investigative Site 009
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Forest Investigative Site 030
      • Springfield, Illinois, United States, 62704
        • Forest Investigative Site 123
    • 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
      • Lexington, Kentucky, United States, 40504
        • Forest Investigative Site 107
      • 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
      • Rockville, Maryland, United States, 20852
        • Forest Investigative Site 165
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 003
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 055
      • New Bedford, Massachusetts, United States, 02740
        • Forest Investigative Site 118
      • Waltham, Massachusetts, United States, 02453
        • Forest Investigative Site 007
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Forest Investigative Site 163
      • 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
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Forest Investigative Site 142
      • St. Louis, Missouri, United States, 63110
        • Forest Investigative Site 143
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Forest Investigative Site 013
      • Omaha, Nebraska, United States, 68114
        • Forest Investigative Site 150
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 072
      • Las Vegas, Nevada, United States, 89117
        • Forest Investigative Site 065
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Forest Investigative Site 147
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site 101
      • Albuquerque, New Mexico, United States, 87102
        • Forest Investigative Site 137
    • New York
      • Albany, New York, United States, 12206
        • Forest Investigative Site 006
      • New Hyde Park, New York, United States, 11042
        • Forest Investigative Site 081
      • New York, New York, United States, 10019
        • Forest Investigative Site 016
      • New York, New York, United States, 10032
        • Forest Investigative Site 151
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Forest Investigative Site 155
      • 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
      • Durham, North Carolina, United States, 27704
        • Forest Investigative Site 135
      • 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
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 082
    • 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
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site 141
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site 159
      • Zanesville, Ohio, United States, 43701
        • Forest Investigative Site 153
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Forest Investigative Site 083
      • 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
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 001
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Forest Investigative Site 130
      • Harleysville, Pennsylvania, United States, 19438
        • Forest Investigative Site 037
      • Jenkintown, Pennsylvania, United States, 19046
        • Forest Investigative Site 126
      • Morrisville, Pennsylvania, United States, 19067
        • Forest Investigative Site 158
      • 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
      • Bristol, Tennessee, United States, 37620
        • Forest Investigative Site 048
      • 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, 75230
        • Forest Investigative Site 071
      • Dallas, Texas, United States, 75235
        • Forest Investigative Site 017
      • Dallas, Texas, United States, 75251
        • Forest Investigative Site 124
      • Desoto, Texas, United States, 75115
        • Forest Investigative Site 162
      • Houston, Texas, United States, 77002
        • Forest Investigative Site 136
      • Houston, Texas, United States, 77079
        • Forest Investigative Site 106
      • Irving, Texas, United States, 75039
        • Forest Investigative Site 014
      • Irving, Texas, United States, 75039
        • Forest Investigative Site 139
      • New Braunfels, Texas, United States, 78130
        • Forest Investigative Site 160
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 109
      • San Antonio, Texas, United States, 78258
        • Forest Investigative Site 119
      • San Antonio, Texas, United States, 78205
        • Forest Investigative Site 146
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Forest Investigative Site 076
    • Virginia
      • Arlington, Virginia, United States, 22204
        • Forest Investigative Site 121
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site 028
    • Washington
      • Renton, Washington, United States, 98057
        • Forest Investigative Site 068
      • 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

Ages Eligible for Study

18 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have successfully completed all required visits of a qualifying Phase 3 core protocol
  • Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dutogliptin
400 mg tablet, once daily
Other Names:
  • PHX1149
Active Comparator: 2
Drug: Sitagliptin
100 mg capsule (each capsule contains two 50-mg tablets), once daily
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Collaborators

Phenomix

Investigators

  • 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

March 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUT-MD-403

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 Diabetes Mellitus, Type 2

Clinical Trials on Dutogliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe