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| Name | Class |
|---|---|
| Phenomix | INDUSTRY |
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This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutogliptin | Drug | 400 mg tablet, once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose. | 52 weeks |
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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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| Sitagliptin | Drug | 100 mg capsule (each capsule contains two 50-mg tablets), once daily |
|
|
| 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 | Goodyear | Arizona | 85395 | United States |
| Forest Investigative Site 080 | Peoria | Arizona | 85381 | United States |
| Forest Investigative Site 098 | Phoenix | Arizona | 85020 | United States |
| Forest Investigative Site 133 | Phoenix | Arizona | 85023 | 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 152 | Anaheim | California | 92804 | 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 140 | Sacramento | California | 95816 | United States |
| Forest Investigative Site 067 | Sacramento | California | 95821 | United States |
| Forest Investigative Site 145 | San Mateo | California | 94401 | United States |
| Forest Investigative Site 112 | Santa Ana | California | 92701 | United States |
| Forest Investigative Site 128 | Tustin | California | 92780 | 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 088 | Denver | Colorado | 80239 | United States |
| Forest Investigative Site 156 | Boca Raton | Florida | 33432 | United States |
| Forest Investigative Site 148 | Brandenton | Florida | 34205 | 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 144 | Hialeah | Florida | 33012 | United States |
| Forest Investigative Site 129 | Hollywood | Florida | 33021 | United States |
| Forest Investigative Site 062 | Jacksonville | Florida | 32205 | United States |
| Forest Investigative Site 161 | Miami | Florida | 33136 | United States |
| Forest Investigative Site 157 | Miami | Florida | 33143 | United States |
| Forest Investigative Site 154 | Miami | Florida | 33175 | United States |
| Forest Investigative Site 050 | Miami | Florida | 33183 | 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 138 | Tamarac | Florida | 33319 | 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 077 | Decatur | Georgia | 30035 | United States |
| Forest Investigative Site 042 | Dunwoody | Georgia | 30338 | 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 123 | Springfield | Illinois | 62704 | 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 107 | Lexington | Kentucky | 40504 | 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 165 | Rockville | Maryland | 20852 | United States |
| Forest Investigative Site 003 | Brockton | Massachusetts | 02301 | United States |
| Forest Investigative Site 055 | Brockton | Massachusetts | 02301 | United States |
| Forest Investigative Site 118 | New Bedford | Massachusetts | 02740 | United States |
| Forest Investigative Site 007 | Waltham | Massachusetts | 02453 | United States |
| Forest Investigative Site 163 | Cadillac | Michigan | 49601 | 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 142 | St Louis | Missouri | 63110 | United States |
| Forest Investigative Site 143 | St Louis | Missouri | 63110 | United States |
| Forest Investigative Site 013 | Grand Island | Nebraska | 68803 | United States |
| Forest Investigative Site 150 | Omaha | Nebraska | 68114 | 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 147 | Berkeley Heights | New Jersey | 07922 | United States |
| Forest Investigative Site 137 | Albuquerque | New Mexico | 87102 | United States |
| Forest Investigative Site 101 | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site 006 | Albany | New York | 12206 | 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 151 | New York | New York | 10032 | United States |
| Forest Investigative Site 155 | Asheboro | North Carolina | 27203 | 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 135 | Durham | North Carolina | 27704 | 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 141 | Marion | Ohio | 43302 | United States |
| Forest Investigative Site 159 | Marion | Ohio | 43302 | United States |
| Forest Investigative Site 153 | Zanesville | Ohio | 43701 | United States |
| Forest Investigative Site 083 | Bethany | Oklahoma | 73008 | 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 001 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 130 | Bensalem | Pennsylvania | 19020 | United States |
| Forest Investigative Site 037 | Harleysville | Pennsylvania | 19438 | United States |
| Forest Investigative Site 126 | Jenkintown | Pennsylvania | 19046 | United States |
| Forest Investigative Site 158 | Morrisville | Pennsylvania | 19067 | 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 048 | Bristol | Tennessee | 37620 | 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 124 | Dallas | Texas | 75251 | United States |
| Forest Investigative Site 162 | DeSoto | Texas | 75115 | United States |
| Forest Investigative Site 136 | Houston | Texas | 77002 | United States |
| Forest Investigative Site 106 | Houston | Texas | 77079 | United States |
| Forest Investigative Site 014 | Irving | Texas | 75039 | United States |
| Forest Investigative Site 139 | Irving | Texas | 75039 | United States |
| Forest Investigative Site 160 | New Braunfels | Texas | 78130 | United States |
| Forest Investigative Site 146 | San Antonio | Texas | 78205 | 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 121 | Arlington | Virginia | 22204 | United States |
| Forest Investigative Site 028 | Virginia Beach | Virginia | 23454 | United States |
| Forest Investigative Site 068 | Renton | Washington | 98057 | United States |
| Forest Investigative Site 092 | Spokane | Washington | 99207 | United States |
| Forest Investigative Site 027 | Milwaukee | Wisconsin | 53209 | United States |
| 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 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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