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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 treatment with pioglitazone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo, oral tablet administered once daily on background of pioglitazone |
|
| 2 | Experimental | dutogliptin, oral tablet administered once daily on background of pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo, oral tablet administered once daily on background of pioglitazone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c Level (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) and Week 8 (Week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose Level (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) and 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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| Dutogliptin |
| Drug |
dutogliptin, oral tablet administered once daily on background of pioglitazone |
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Forest Investigative Site 059 | Chandler | Arizona | 85225 | United States |
| Forest Investigative Site 096 | Litchfield | Arizona | 85340 | United States |
| Forest Investigative Site 098 | Phoenix | Arizona | 85020 | United States |
| Forest Investigative Site 044 | Scottsdale | Arizona | 85254 | United States |
| Forest Investigative Site 087 | Tucson | Arizona | 85741 | 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 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 115 | Colorado Springs | Colorado | 80910 | United States |
| Forest Investigative Site 073 | Clearwater | Florida | 33765 | United States |
| Forest Investigative Site 004 | Daytona Beach | Florida | 32117 | United States |
| Forest Investigative Site 052 | DeLand | Florida | 32720 | United States |
| Forest Investigative Site 062 | Jacksonville | Florida | 32205 | United States |
| Forest Investigative Site 021 | Miami | Florida | 33169 | United States |
| Forest Investigative Site 050 | Miami | Florida | 33183 | United States |
| Forest Investigative Site 122 | Miami | Florida | 33186 | United States |
| Forest Investigative Site 015 | Orlando | Florida | 32806 | 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 009 | Meridian | Idaho | 83646 | United States |
| Forest Investigative Site 60 | Melrose Park | Illinois | 60160 | 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 078 | Erlanger | Kentucky | 41018 | United States |
| Forest Investigative Site 024 | Madisonville | Kentucky | 42431 | 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 118 | New Bedford | Massachusetts | 02740 | United States |
| Forest Investigative Site 007 | Waltham | Massachusetts | 02453 | 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 013 | Grand Island | Nebraska | 68803 | 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 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 117 | Charlotte | North Carolina | 28277 | 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 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 149 | Norman | Oklahoma | 73069 | United States |
| Forest Investigative Site 102 | Ashland | Oregon | 97520 | United States |
| Forest Investigative Site 005 | Eugene | Oregon | 97404 | United States |
| Forest Investigative Site 037 | Harleysville | Pennsylvania | 19438 | 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 090 | Manning | South Carolina | 29102 | 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 017 | Dallas | Texas | 75235 | United States |
| Forest Investigative Site 124 | Dallas | Texas | 75251 | United States |
| Forest Investigative Site 106 | Houston | Texas | 77079 | United States |
| Forest Investigative Site 014 | Irving | Texas | 75039 | United States |
| Forest Investigative Site 109 | San Antonio | Texas | 78229 | 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 092 | Spokane | Washington | 99207 | United States |
| Forest Investigative Site 027 | Milwaukee | Wisconsin | 53209 | United States |
| Forest Investigative Site 209 | Mogilev | Belarus | 212030 | Belarus |
| Forest Investigative Site 401 | Dresden | Germany | 01099 | Germany |
| Forest Investigative Site 402 | Dresden | Germany | 01307 | Germany |
| Forest Investigative Site 403 | Mainz | Germany | 55116 | Germany |
| Forest Investigative Site 614 | Vijayawada | Andhra Pradesh | 520002 | 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 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 | Lithunia | 48259 | Lithuania |
| Forest Investigative Site 703 | Kaunas | Lithunia | 49456 | Lithuania |
| Forest Investigative Site 704 | Klaipėda | Lithunia | 92288 | Lithuania |
| Forest Investigative Site 705 | Vilnius | Lithunia | 09112 | Lithuania |
| 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 Romania | 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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