Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Forest Investigative Site 064
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Birmingham, Alabama, Forenede Stater, 35235
- Forest Investigative Site 020
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Arizona
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Chandler, Arizona, Forenede Stater, 85225
- Forest Investigative Site 059
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Litchfield, Arizona, Forenede Stater, 85340
- Forest Investigative Site 096
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Phoenix, Arizona, Forenede Stater, 85020
- Forest Investigative Site 098
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Scottsdale, Arizona, Forenede Stater, 85254
- Forest Investigative Site 044
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Tucson, Arizona, Forenede Stater, 85741
- Forest Investigative Site 087
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California
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Anaheim, California, Forenede Stater, 92801
- Forest Investigative Site 061
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Chula Vista, California, Forenede Stater, 91911
- Forest Investigative Site 041
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Encinitas, California, Forenede Stater, 92024
- Forest Investigative Site 049
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Greenbrae, California, Forenede Stater, 94904
- Forest Investigative Site 022
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Harbor City, California, Forenede Stater, 90710
- Forest Investigative Site 047
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Huntington Park, California, Forenede Stater, 90255
- Forest Investigative Site 010
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Northridge, California, Forenede Stater, 91325
- Forest Investigative Site 111
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Riverside, California, Forenede Stater, 92506
- Forest Investigative Site 031
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Roseville, California, Forenede Stater, 95661
- Forest Investigative Site 091
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Sacramento, California, Forenede Stater, 95821
- Forest Investigative Site 067
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Santa Ana, California, Forenede Stater, 92701
- Forest Investigative Site 112
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Walnut Creek, California, Forenede Stater, 94598
- Forest Investigative Site 011
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West Hills, California, Forenede Stater, 91307
- Forest Investigative Site 063
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
- Forest Investigative Site 115
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Florida
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Clearwater, Florida, Forenede Stater, 33765
- Forest Investigative Site 073
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Daytona Beach, Florida, Forenede Stater, 32117
- Forest Investigative Site 004
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DeLand, Florida, Forenede Stater, 32720
- Forest Investigative Site 052
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Jacksonville, Florida, Forenede Stater, 32205
- Forest Investigative Site 062
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Miami, Florida, Forenede Stater, 33169
- Forest Investigative Site 021
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Miami, Florida, Forenede Stater, 33186
- Forest Investigative Site 122
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Miami, Florida, Forenede Stater, 33183
- Forest Investigative Site 050
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Orlando, Florida, Forenede Stater, 32806
- Forest Investigative Site 015
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Sarasota, Florida, Forenede Stater, 34239
- Forest Investigative Site 018
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St. Petersburg, Florida, Forenede Stater, 33716
- Forest Investigative Site 075
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West Palm Beach, Florida, Forenede Stater, 33401
- Forest Investigative Site 026
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Georgia
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Atlanta, Georgia, Forenede Stater, 30338
- Forest Investigative Site 045
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Augusta, Georgia, Forenede Stater, 30909
- Forest Investigative Site 079
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Idaho
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Meridian, Idaho, Forenede Stater, 83646
- Forest Investigative Site 009
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Illinois
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Melrose Park, Illinois, Forenede Stater, 60160
- Forest Investigative Site 60
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Peoria, Illinois, Forenede Stater, 61614
- Forest Investigative Site 030
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Indiana
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Evansville, Indiana, Forenede Stater, 47710
- Forest Investigative Site 100
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Evansville, Indiana, Forenede Stater, 47713
- Forest Investigative Site 097
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Forest Investigative Site 053
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Wichita, Kansas, Forenede Stater, 67203
- Forest Investigative Site 008
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Kentucky
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Erlanger, Kentucky, Forenede Stater, 41018
- Forest Investigative Site 078
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Madisonville, Kentucky, Forenede Stater, 42431
- Forest Investigative Site 024
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Louisiana
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Covington, Louisiana, Forenede Stater, 70433
- Forest Investigative Site 034
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
- Forest Investigative Site 035
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Oxon Hill, Maryland, Forenede Stater, 20745
- Forest Investigative Site 046
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Massachusetts
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New Bedford, Massachusetts, Forenede Stater, 02740
- Forest Investigative Site 118
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Waltham, Massachusetts, Forenede Stater, 02453
- Forest Investigative Site 007
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Michigan
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Dearborn, Michigan, Forenede Stater, 48126
- Forest Investigative Site 002
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St. Clair Shores, Michigan, Forenede Stater, 48081
- Forest Investigative Site 029
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Minnesota
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Edina, Minnesota, Forenede Stater, 55435
- Forest Investigative Site 054
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Forest Investigative Site 013
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89101
- Forest Investigative Site 072
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Las Vegas, Nevada, Forenede Stater, 89117
- Forest Investigative Site 065
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New York
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New Hyde Park, New York, Forenede Stater, 11042
- Forest Investigative Site 081
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New York, New York, Forenede Stater, 10019
- Forest Investigative Site 016
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Forest Investigative Site 094
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Charlotte, North Carolina, Forenede Stater, 28209
- Forest Investigative Site 051
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Charlotte, North Carolina, Forenede Stater, 28277
- Forest Investigative Site 117
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Lenoir, North Carolina, Forenede Stater, 28645
- Forest Investigative Site 058
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Morehead City, North Carolina, Forenede Stater, 28557
- Forest Investigative Site 038
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Salisbury, North Carolina, Forenede Stater, 28144
- Forest Investigative Site 040
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Ohio
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Akron, Ohio, Forenede Stater, 44311
- Forest Investigative Site 039
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Cincinnati, Ohio, Forenede Stater, 45242
- Forest Investigative Site 023
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Columbus, Ohio, Forenede Stater, 43201
- Forest Investigative Site 043
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Dayton, Ohio, Forenede Stater, 45406
- Forest Investigative Site 057
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Kettering, Ohio, Forenede Stater, 45429
- Forest Investigative Site 032
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Oklahoma
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Norman, Oklahoma, Forenede Stater, 73069
- Forest Investigative Site 149
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Oregon
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Ashland, Oregon, Forenede Stater, 97520
- Forest Investigative Site 102
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Eugene, Oregon, Forenede Stater, 97404
- Forest Investigative Site 005
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Pennsylvania
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Harleysville, Pennsylvania, Forenede Stater, 19438
- Forest Investigative Site 037
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Philadelphia, Pennsylvania, Forenede Stater, 19152
- Forest Investigative Site 066
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Tipton, Pennsylvania, Forenede Stater, 16684
- Forest Investigative Site 036
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South Carolina
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Greer, South Carolina, Forenede Stater, 29651
- Forest Investigative Site 103
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Manning, South Carolina, Forenede Stater, 29102
- Forest Investigative Site 090
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Pelzer, South Carolina, Forenede Stater, 29669
- Forest Investigative Site 033
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Forest Investigative Site 114
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Chattanooga, Tennessee, Forenede Stater, 37421
- Forest Investigative Site 104
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Texas
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Arlington, Texas, Forenede Stater, 76014
- Forest Investigative Site 099
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Corpus Christi, Texas, Forenede Stater, 78404
- Forest Investigative Site 056
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Dallas, Texas, Forenede Stater, 75235
- Forest Investigative Site 017
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Dallas, Texas, Forenede Stater, 75251
- Forest Investigative Site 124
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Houston, Texas, Forenede Stater, 77079
- Forest Investigative Site 106
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Irving, Texas, Forenede Stater, 75039
- Forest Investigative Site 014
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San Antonio, Texas, Forenede Stater, 78229
- Forest Investigative Site 109
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Forest Investigative Site 076
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23454
- Forest Investigative Site 028
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Washington
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Spokane, Washington, Forenede Stater, 99207
- Forest Investigative Site 092
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53209
- Forest Investigative Site 027
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Mogilev, Hviderusland, 212030
- Forest Investigative Site 209
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, Indien, 520002
- Forest Investigative Site 614
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Gujarat
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Ahmedabad, Gujarat, Indien, 380015
- Forest Investigative Site 618
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Karnal
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Haryana, Karnal, Indien, 132001
- Forest Investigative Site 620
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Karnataka
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Bangalore, Karnataka, Indien, 560003
- Forest Investigative Site 607
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Bangalore, Karnataka, Indien, 560010
- Forest Investigative Site 606
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Bangalore, Karnataka, Indien, 560043
- Forest Investigative Site 602
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Bangalore, Karnataka, Indien, 560092
- Forest Investigative Site 604
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Mangalore, Karnataka, Indien, 575003
- Forest Investigative Site 601
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Maharashtra
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Nagpur, Maharashtra, Indien, 440012
- Forest Investigative Site 616
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Nasik, Maharashtra, Indien, 380015
- Forest Investigative Site 617
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Pune, Maharashtra, Indien, 411037
- Forest Investigative Site 612
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Tamil Nadu
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Channi, Tamil Nadu, Indien, 600020
- Forest Investigative Site 603
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Chennai, Tamil Nadu, Indien, 600013
- Forest Investigative Site 613
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Vellore, Tamil Nadu, Indien, 632009
- Forest Investigative Site 615
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Lithunia
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Kaunas, Lithunia, Litauen, 48259
- Forest Investigative Site 702
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Kaunas, Lithunia, Litauen, 49456
- Forest Investigative Site 703
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Klaipeda, Lithunia, Litauen, 92288
- Forest Investigative Site 704
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Vilnius, Lithunia, Litauen, 09112
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Bacau, Rumænien, 600164
- Forest Investigative Site 909
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Bucuresti, Rumænien, 010584
- Forest Investigative Site 906
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Bucuresti, Rumænien, 020725
- Forest Investigative Site 908
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Satu Mare, Rumænien, 440055
- Forest Investigative Site 903
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Sibiu, Rumænien, 550245
- Forest Investigative Site 901
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Tg Mures, Rumænien, 540142
- Forest Investigative Site 905 Romania
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Timisoara, Rumænien, 300736
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Dresden, Tyskland, 01099
- Forest Investigative Site 401
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Dresden, Tyskland, 01307
- Forest Investigative Site 402
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Mainz, Tyskland, 55116
- Forest Investigative Site 403
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: 1
placebo, oral tablet administered once daily on background of pioglitazone
|
placebo, oral tablet administered once daily on background of pioglitazone
|
|
Eksperimentel: 2
dutogliptin, oral tablet administered once daily on background of pioglitazone
|
dutogliptin, oral tablet administered once daily on background of pioglitazone
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hemoglobin A1c Level (HbA1c)
Tidsramme: 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)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fasting Plasma Glucose Level (FPG)
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Kaity Posada, PharmD, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- DUT-MD-304
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