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| Name | Class |
|---|---|
| Phenomix | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutogliptin | Active Comparator | Dutogliptin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutogliptin | Drug | Dutogliptin oral administration once daily on background of glimepiride with or without metformin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaity Posada, PharmD | Forest Research Institute, a subsidiary of Forest Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 064 | Birmingham | Alabama | 35205 | United States | ||
| Forest Investigative Site 020 |
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| Placebo | Drug | Placebo, oral administration once daily on background of glimepiride with or without metformin |
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Forest Investigative Site 025 | Muscle Shoals | Alabama | 35661 | United States |
| Forest Investigative Site 059 | Chandler | Arizona | 85225 | United States |
| Forest Investigative Site 113 | Gilbert | Arizona | 85295 | United States |
| Forest Investigative Site 096 | Litchfield | Arizona | 85340 | United States |
| Forest Investigative Site 080 | Peoria | Arizona | 85381 | United States |
| Forest Investigative Site 098 | Phoenix | Arizona | 85020 | United States |
| Forest Investigative Site 044 | Scottsdale | Arizona | 85254 | United States |
| Forest Investigative Site 061 | Anaheim | California | 92801 | United States |
| Forest Investigative Site 041 | Chula Vista | California | 91911 | United States |
| Forest Investigative Site 049 | Encinitas | California | 92024 | United States |
| Forest Investigative Site 022 | Greenbrae | California | 94904 | United States |
| Forest Investigative Site 047 | Harbor City | California | 90710 | United States |
| Forest Investigative Site 010 | Huntington Park | California | 90255 | United States |
| Forest Investigative Site 070 | Los Angeles | California | 90057 | United States |
| Forest Investigative Site 111 | Northridge | California | 91325 | United States |
| Forest Investigative Site 031 | Riverside | California | 92506 | United States |
| Forest Investigative Site 091 | Roseville | California | 95661 | United States |
| Forest Investigative Site 067 | Sacramento | California | 95821 | United States |
| Forest Investigative Site 112 | Santa Ana | California | 92701 | United States |
| Forest Investigative Site 011 | Walnut Creek | California | 94598 | United States |
| Forest Investigative Site 063 | West Hills | California | 91307 | United States |
| Forest Investigative Site 088 | Denver | Colorado | 80239 | United States |
| Forest Investigative Site 156 | Boca Raton | Florida | 33432 | United States |
| Forest Investigative Site 004 | Daytona Beach | Florida | 32117 | United States |
| Forest Investigative Site 052 | DeLand | Florida | 32720 | United States |
| Forest Investigative Site 129 | Hollywood | Florida | 33021 | United States |
| Forest Investigative Site 062 | Jacksonville | Florida | 32205 | United States |
| Forest Investigative Site 050 | Miami | Florida | 33156 | United States |
| Forest Investigative Site 021 | Miami | Florida | 33169 | United States |
| Forest Investigative Site 122 | Miami | Florida | 33186 | United States |
| Forest Investigative Site 125 | Miami Lakes | Florida | 33014 | United States |
| Forest Investigative Site 069 | New Port Richey | Florida | 34652 | United States |
| Forest Investigative Site 012 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 015 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 131 | Ormond Beach | Florida | 32174 | United States |
| Forest Investigative Site 127 | Pembroke Pines | Florida | 33028 | United States |
| Forest Investigative Site 018 | Sarasota | Florida | 34239 | United States |
| Forest Investigative Site 075 | St. Petersburg | Florida | 33716 | United States |
| Forest Investigative Site 026 | West Palm Beach | Florida | 33401 | United States |
| Forest Investigative Site 045 | Atlanta | Georgia | 30338 | United States |
| Forest Investigative Site 079 | Augusta | Georgia | 30909 | United States |
| Forest Investigative Site 084 | Roswell | Georgia | 30076 | United States |
| Forest Investigative Site 132 | Roswell | Georgia | 30076 | United States |
| Forest Investigative Site 009 | Meridian | Idaho | 83646 | United States |
| Forest Investigative Site 030 | Peoria | Illinois | 61614 | United States |
| Forest Investigative Site 100 | Evansville | Indiana | 47710 | United States |
| Forest Investigative Site 097 | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site 053 | Kansas City | Kansas | 66160 | United States |
| Forest Investigative Site 008 | Wichita | Kansas | 67203 | United States |
| Forest Investigative Site 107 | Lexington | Kentucky | 40504 | United States |
| Forest Investigative Site 034 | Covington | Louisiana | 70433 | United States |
| Forest Investigative Site 035 | Baltimore | Maryland | 21204 | United States |
| Forest Investigative Site 046 | Oxon Hill | Maryland | 20745 | United States |
| Forest Investigative Site 003 | Brockton | Massachusetts | 02301 | United States |
| Forest Investigative Site 055 | Brockton | Massachusetts | 23301 | United States |
| Forest Investigative Site 118 | New Bedford | Massachusetts | 02740 | United States |
| Forest Investigative Site 007 | Waltham | Massachusetts | 24453 | United States |
| Forest Investigative Site 002 | Dearborn | Michigan | 48126 | United States |
| Forest Investigative Site 029 | Saint Clair Shores | Michigan | 48081 | United States |
| Forest Investigative Site 054 | Edina | Minnesota | 55435 | United States |
| Forest Investigative Site 072 | Las Vegas | Nevada | 89101 | United States |
| Forest Investigative Site 065 | Las Vegas | Nevada | 89117 | United States |
| Forest Investigative Site 101 | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site 081 | New Hyde Park | New York | 11042 | United States |
| Forest Investigative Site 016 | New York | New York | 10019 | United States |
| Forest Investigative Site 094 | Charlotte | North Carolina | 28204 | United States |
| Forest Investigative Site 051 | Charlotte | North Carolina | 28209 | United States |
| Forest Investigative Site 058 | Lenoir | North Carolina | 28645 | United States |
| Forest Investigative Site 038 | Morehead City | North Carolina | 28557 | United States |
| Forest Investigative Site 040 | Salisbury | North Carolina | 28144 | United States |
| Forest Investigative Site 082 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site 039 | Akron | Ohio | 44311 | United States |
| Forest Investigative Site 023 | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site 043 | Columbus | Ohio | 43201 | United States |
| Forest Investigative Site 057 | Dayton | Ohio | 45406 | United States |
| Forest Investigative Site 032 | Kettering | Ohio | 45429 | United States |
| Forest Investigative Site 083 | Bethany | Oklahoma | 73008 | United States |
| Forest Investigative Site 005 | Eugene | Oregon | 97404 | United States |
| Forest Investigative Site 001 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 126 | Jenkintown | Pennsylvania | 19046 | United States |
| Forest Investigative Site 066 | Philadelphia | Pennsylvania | 19152 | United States |
| Forest Investigative Site 036 | Tipton | Pennsylvania | 16684 | United States |
| Forest Investigative Site 103 | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site 033 | Pelzer | South Carolina | 29669 | United States |
| Forest Investigative Site 114 | Chattanooga | Tennessee | 37404 | United States |
| Forest Investigative Site 104 | Chattanooga | Tennessee | 37421 | United States |
| Forest Investigative Site 099 | Arlington | Texas | 76014 | United States |
| Forest Investigative Site 056 | Corpus Christi | Texas | 78404 | United States |
| Forest Investigative Site 071 | Dallas | Texas | 75230 | United States |
| Forest Investigative Site 017 | Dallas | Texas | 75235 | United States |
| Forest Investigative Site 014 | Irving | Texas | 75039 | United States |
| Forest Investigative Site 109 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 119 | San Antonio | Texas | 78258 | United States |
| Forest Investigative Site 076 | Salt Lake City | Utah | 84107 | United States |
| Forest Investigative Site 028 | Virginia Beach | Virginia | 23454 | United States |
| Forest Investigative Site 068 | Renton | Washington | 98057 | United States |
| Forest Investigative Site 208 | Grodno | Belarus | 230015 | Belarus |
| Forest Investigative Site 202 | Homyel | Belarus | 236029 | Belarus |
| Forest Investigative Site 207 | Minsk | Belarus | 220114 | Belarus |
| Forest Investigative Site 209 | Mogilev | Belarus | 212030 | Belarus |
| Forest Investigative Site 206 | Vitebsk | Belarus | 210037 | Belarus |
| Forest Investigative Site 302 | Medellín | Antioquia | Colombia |
| Forest Investigative Site 506 | Budapest | Hungary | H-1083 | Hungary |
| Forest Investigative Site 504 | Szentes | Hungary | H-6600 | Hungary |
| Forest Investigative Site 621 | Hyderabad | Andhra Pradesh | 500034 | India |
| Forest Investigative Site 614 | Vijayawada | Andhra Pradesh | 520002 | India |
| Forest Investigative Site 610 | Visakhapatanam | Andhra Pradesh | 530002 | India |
| Forest Investigative Site 609 | Mapusa | Goa | 403507 | India |
| Forest Investigative Site 618 | Ahmedabad | Gujarat | 380015 | India |
| Forest Investigative Site 620 | Haryāna | Karnal | 132001 | India |
| Forest Investigative Site 607 | Bangalore | Karnataka | 560003 | India |
| Forest Investigative Site 606 | Bangalore | Karnataka | 560010 | India |
| Forest Investigative Site 602 | Bangalore | Karnataka | 560043 | India |
| Forest Investigative Site 604 | Bangalore | Karnataka | 560092 | India |
| Forest Investigative Site 601 | Mangalore | Karnataka | 575003 | India |
| Forest Investigative Site 619 | Palakkad | Kerala | 678013 | India |
| Forest Investigative Site 616 | Nagpur | Maharashtra | 440012 | India |
| Forest Investigative Site 617 | Nashik | Maharashtra | 380015 | India |
| Forest Investigative Site 612 | Pune | Maharashtra | 411037 | India |
| Forest Investigative Site 603 | Channi | Tamil Nadu | 600020 | India |
| Forest Investigative Site 613 | Chennai | Tamil Nadu | 600013 | India |
| Forest Investigative Site 615 | Vellore | Tamil Nadu | 632009 | India |
| Forest Investigative Site 702 | Kaunas | Lithuania | 48259 | Lithuania |
| Forest Investigative Site 703 | Kaunas | Lithuania | 49456 | Lithuania |
| Forest Investigative Site 701 | Kaunas | Lithuania | 51270 | Lithuania |
| Forest Investigative Site 704 | Klaipėda | Lithuania | 92288 | Lithuania |
| Forest Investigative Site 705 | Vilnius | Lithuania | 09112 | Lithuania |
| Forest Investigative Site 804 | Arequipa | Arequipa | 804 | Peru |
| Forest Investigative Site 803 | Arequipa | Arequipa | Peru |
| Forest Investigative Site 812 | Trujillo | La Libertad | Peru |
| Forest Investigative Site 811 | Chiclayo | Lambayeque | Peru |
| Forest Investigative Site 805 | Lima | Lima Province | Lima 14 | Peru |
| Forest Investigative Site 813 | Lima | Lima Province | Lima 17 | Peru |
| Forest Investigative Site 801 | Lima | Lima Province | Lima 27 | Peru |
| Forest Investigative Site 807 | Lima | Lima Province | Lima 27 | Peru |
| Forest Investigative Site 809 | Lima | Lima Province | Lima 33 | Peru |
| Forest Investigative Site 808 | Lima | Lima Province | Lima 41 | Peru |
| Forest Investigative Site 802 | Piura | Piura | Peru |
| Forest Investigative Site 909 | Bacau | Romania | 600164 | Romania |
| Forest Investigative Site 906 | Bucharest | Romania | 010584 | Romania |
| Forest Investigative Site 908 | Bucharest | Romania | 020725 | Romania |
| Forest Investigative Site 903 | Satu Mare | Romania | 440055 | Romania |
| Forest Investigative Site 901 | Sibiu | Romania | 550245 | Romania |
| Forest Investigative Site 905 | Tg Mures | Romania | 540142 | Romania |
| Forest Investigative Site 902 | Timișoara | Romania | 300736 | Romania |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C552164 | dutogliptin |
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