Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

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 Glimepiride With or Without Metformin

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

677

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

  • Belarus
      • Gomel, Belarus, 236029
        • Forest Investigative Site 202
      • Grodno, Belarus, 230015
        • Forest Investigative Site 208
      • Minsk, Belarus, 220114
        • Forest Investigative Site 207
      • Mogilev, Belarus, 212030
        • Forest Investigative Site 209
      • Vitebsk, Belarus, 210037
        • Forest Investigative Site 206
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Forest Investigative Site 302
  • Hungary
      • Budapest, Hungary, H-1083
        • Forest Investigative Site 506
      • Szentes, Hungary, H-6600
        • Forest Investigative Site 504
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Forest Investigative Site 621
      • Vijayawada, Andhra Pradesh, India, 520002
        • Forest Investigative Site 614
      • Visakhapatanam, Andhra Pradesh, India, 530002
        • Forest Investigative Site 610
    • Goa
      • Mapusa, Goa, India, 403507
        • Forest Investigative Site 609
    • 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
    • Kerala
      • Palakkad, Kerala, India, 678013
        • Forest Investigative Site 619
    • 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
      • Kaunas, Lithuania, 48259
        • Forest Investigative Site 702
      • Kaunas, Lithuania, 49456
        • Forest Investigative Site 703
      • Kaunas, Lithuania, 51270
        • Forest Investigative Site 701
      • Klaipeda, Lithuania, 92288
        • Forest Investigative Site 704
      • Vilnius, Lithuania, 09112
        • Forest Investigative Site 705
  • Peru
      • Arequipa, Peru, 804
        • Forest Investigative Site 804
      • Arequipa, Peru
        • Forest Investigative Site 803
      • Lima, Peru, Lima 14
        • Forest Investigative Site 805
      • Lima, Peru, Lima 17
        • Forest Investigative Site 813
      • Lima, Peru, Lima 27
        • Forest Investigative Site 801
      • Lima, Peru, Lima 27
        • Forest Investigative Site 807
      • Lima, Peru, Lima 33
        • Forest Investigative Site 809
      • Lima, Peru, Lima 41
        • Forest Investigative Site 808
      • Piura, Peru
        • Forest Investigative Site 802
    • La Libertad
      • Trujillo, La Libertad, Peru
        • Forest Investigative Site 812
    • Lambayeque
      • Chiclayo, Lambayeque, Peru
        • Forest Investigative Site 811
  • 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
      • 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
      • 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
      • Litchfield, Arizona, United States, 85340
        • Forest Investigative Site 096
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site 080
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 098
      • Scottsdale, Arizona, United States, 85254
        • Forest Investigative Site 044
    • 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
      • 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
      • 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
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site 088
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Forest Investigative Site 156
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site 004
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site 052
      • Hollywood, Florida, United States, 33021
        • Forest Investigative Site 129
      • Jacksonville, Florida, United States, 32205
        • Forest Investigative Site 062
      • Miami, Florida, United States, 33156
        • Forest Investigative Site 050
      • Miami, Florida, United States, 33169
        • Forest Investigative Site 021
      • Miami, Florida, United States, 33186
        • Forest Investigative Site 122
      • 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
      • 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
      • 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
    • 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
      • Lexington, Kentucky, United States, 40504
        • Forest Investigative Site 107
    • 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
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 003
      • Brockton, Massachusetts, United States, 23301
        • Forest Investigative Site 055
      • New Bedford, Massachusetts, United States, 02740
        • Forest Investigative Site 118
      • Waltham, Massachusetts, United States, 24453
        • 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
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 072
      • Las Vegas, Nevada, United States, 89117
        • Forest Investigative Site 065
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site 101
    • 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
      • 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
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Forest Investigative Site 083
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site 005
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 001
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Forest Investigative Site 126
      • 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
      • 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, 75230
        • Forest Investigative Site 071
      • Dallas, Texas, United States, 75235
        • Forest Investigative Site 017
      • Irving, Texas, United States, 75039
        • Forest Investigative Site 014
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 109
      • San Antonio, Texas, United States, 78258
        • Forest Investigative Site 119
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Forest Investigative Site 076
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site 028
    • Washington
      • Renton, Washington, United States, 98057
        • Forest Investigative Site 068

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, 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 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: Placebo
Drug: Placebo
Placebo, oral administration once daily on background of glimepiride with or without metformin
Active Comparator: Dutogliptin
Drug: Dutogliptin
Dutogliptin oral administration once daily on background of glimepiride with or without metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c (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), Visit 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), Visit 8 (Week 26).

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Plasma Glucose (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), 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), Visit 8 (Week 26).

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

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUT-MD-303

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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