Dose Ranging Study With LT, Monotherapy, PPAR
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00240383
Collaborator
(none)
1,260
272
49
4.6
0.1
Study Details
Study Description
Brief Summary
A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes
Study Start Date
:
May 1, 2002
Actual Primary Completion Date
:
Jun 1, 2006
Actual Study Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
- To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2 []
Secondary Outcome Measures
- To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- HbA1c > 7.0% and ≤ 10.0% obtained at the Screening visit.
-
- Men and women, 18-70 years of age Established Type 2 diabetes
Exclusion Criteria:
-
- Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
-
- Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
-
- Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Anniston | Alabama | United States | |
| 2 | Local Institution | Birmingham | Alabama | United States | |
| 3 | Local Institution | Huntsville | Alabama | United States | |
| 4 | Local Institution | Hot Springs | Arizona | United States | |
| 5 | Local Institution | Mesa | Arizona | United States | |
| 6 | Local Institution | Phoenix | Arizona | United States | |
| 7 | Local Institution | Tempe | Arizona | United States | |
| 8 | Local Institution | Tucson | Arizona | United States | |
| 9 | Local Institution | Fayette | Arkansas | United States | |
| 10 | Local Institution | Little Rock | Arkansas | United States | |
| 11 | Local Institution | Bakersfield | California | United States | |
| 12 | Local Institution | Concord | California | United States | |
| 13 | Local Institution | Encinitas | California | United States | |
| 14 | Local Institution | Fair Oaks | California | United States | |
| 15 | Local Institution | Fountain Valley | California | United States | |
| 16 | Local Institution | Fresno | California | United States | |
| 17 | Local Institution | La Jolla | California | United States | |
| 18 | Local Institution | Los Gatos | California | United States | |
| 19 | Local Institution | Orange | California | United States | |
| 20 | Local Institution | Raleigh | California | United States | |
| 21 | Local Institution | Riverside | California | United States | |
| 22 | Local Institution | Rolling Hills Estate | California | United States | |
| 23 | Local Institution | Roseville | California | United States | |
| 24 | Local Institution | Sacramento | California | United States | |
| 25 | Local Institution | San Diego | California | United States | |
| 26 | Local Institution | Santa Ana | California | United States | |
| 27 | Local Institution | Santa Barbara | California | United States | |
| 28 | Local Institution | Spring Valley | California | United States | |
| 29 | Local Institution | Tustin | California | United States | |
| 30 | Local Institution | Walnut Creek | California | United States | |
| 31 | Local Institution | Colorado Springs | Colorado | United States | |
| 32 | Local Institution | Golden | Colorado | United States | |
| 33 | Local Institution | Littleton | Colorado | United States | |
| 34 | Local Institution | Nederland | Colorado | United States | |
| 35 | Local Institution | Wheat Ridge | Colorado | United States | |
| 36 | Local Institution | New Britain | Connecticut | United States | |
| 37 | Local Institution | Brandon | Florida | United States | |
| 38 | Local Institution | Chipley | Florida | United States | |
| 39 | Local Institution | Coral Gables | Florida | United States | |
| 40 | Local Institution | Daytona Beach | Florida | United States | |
| 41 | Local Institution | Ft. Lauderdale | Florida | United States | |
| 42 | Local Institution | Hollywood | Florida | United States | |
| 43 | Local Institution | Jacksonville | Florida | United States | |
| 44 | Local Institution | Jupiter | Florida | United States | |
| 45 | Local Institution | Melbourne | Florida | United States | |
| 46 | Local Institution | Miami | Florida | United States | |
| 47 | Local Institution | Ocala | Florida | United States | |
| 48 | Local Institution | Ocoee | Florida | United States | |
| 49 | Local Institution | Orlando | Florida | United States | |
| 50 | Local Institution | Pensacola | Florida | United States | |
| 51 | Local Institution | St. Petersburg | Florida | United States | |
| 52 | Local Institution | Tallahassee | Florida | United States | |
| 53 | Local Institution | Tamarac | Florida | United States | |
| 54 | Local Institution | Titusville | Florida | United States | |
| 55 | Local Institution | West Palm Beach | Florida | United States | |
| 56 | Local Institution | Atlanta | Georgia | United States | |
| 57 | Local Institution | Dunwoody | Georgia | United States | |
| 58 | Local Institution | Honolulu | Hawaii | United States | |
| 59 | Local Institution | Chicago | Illinois | United States | |
| 60 | Local Institution | Vernon Hills | Illinois | United States | |
| 61 | Local Institution | Arkansas City | Kansas | United States | |
| 62 | Local Institution | Shawnee Mission | Kansas | United States | |
| 63 | Local Institution | Wichita | Kansas | United States | |
| 64 | Local Institution | Bardstown | Kentucky | United States | |
| 65 | Local Institution | Lexington | Kentucky | United States | |
| 66 | Local Institution | Louisville | Kentucky | United States | |
| 67 | Local Institution | Richmond | Kentucky | United States | |
| 68 | Local Institution | Metairie | Louisiana | United States | |
| 69 | Local Institution | Slidell | Louisiana | United States | |
| 70 | Local Institution | Bangor | Maine | United States | |
| 71 | Local Institution | Baltimore | Maryland | United States | |
| 72 | Local Institution | Chevy Chase | Maryland | United States | |
| 73 | Local Institution | Norwood | Massachusetts | United States | |
| 74 | Local Institution | Springfield | Massachusetts | United States | |
| 75 | Local Institution | Swansea | Massachusetts | United States | |
| 76 | Local Institution | Worcester | Massachusetts | United States | |
| 77 | Local Institution | Birmingham | Michigan | United States | |
| 78 | Local Institution | Petoskey | Michigan | United States | |
| 79 | Local Institution | Arden Hills | Minnesota | United States | |
| 80 | Local Institution | Bay Saint Louis | Mississippi | United States | |
| 81 | Local Institution | Cleveland | Mississippi | United States | |
| 82 | Local Institution | Jackson | Mississippi | United States | |
| 83 | Local Institution | Olive Branch | Mississippi | United States | |
| 84 | Local Institution | Rolling Fork | Mississippi | United States | |
| 85 | Local Institution | Excelsior Springs | Missouri | United States | |
| 86 | Local Institution | Kansas City | Missouri | United States | |
| 87 | Local Institution | Springfield | Missouri | United States | |
| 88 | Local Institution | St. Louis | Missouri | United States | |
| 89 | Local Institution | Omaha | Nebraska | United States | |
| 90 | Local Institution | Las Vegas | Nevada | United States | |
| 91 | Local Institution | Toms River | New Jersey | United States | |
| 92 | Local Institution | Albuquerque | New Mexico | United States | |
| 93 | Local Institution | Buffalo | New York | United States | |
| 94 | Local Institution | Camillus | New York | United States | |
| 95 | Local Institution | Endicott | New York | United States | |
| 96 | Local Institution | Johnson City | New York | United States | |
| 97 | Local Institution | New Hyde Park | New York | United States | |
| 98 | Local Institution | New York | New York | United States | |
| 99 | Local Institution | Cary | North Carolina | United States | |
| 100 | Local Institution | Charlotte | North Carolina | United States | |
| 101 | Local Institution | Greensboro | North Carolina | United States | |
| 102 | Local Institution | High Point | North Carolina | United States | |
| 103 | Local Institution | Moorehead City | North Carolina | United States | |
| 104 | Local Institution | Raleigh | North Carolina | United States | |
| 105 | Local Institution | Avon | Ohio | United States | |
| 106 | Local Institution | Beavercreek | Ohio | United States | |
| 107 | Local Institution | Bellbrook | Ohio | United States | |
| 108 | Local Institution | Canton | Ohio | United States | |
| 109 | Local Institution | Cincinnati | Ohio | United States | |
| 110 | Local Institution | Cleveland | Ohio | United States | |
| 111 | Local Institution | Colombus | Ohio | United States | |
| 112 | Local Institution | Lyndhurst | Ohio | United States | |
| 113 | Local Institution | Massillon | Ohio | United States | |
| 114 | Local Institution | Zanesville | Ohio | United States | |
| 115 | Local Institution | Tulsa | Oklahoma | United States | |
| 116 | Local Institution | Eugene | Oregon | United States | |
| 117 | Local Institution | Medford | Oregon | United States | |
| 118 | Local Institution | Portland | Oregon | United States | |
| 119 | Local Institution | Reading | Pennsylvania | United States | |
| 120 | Local Institution | Cranston | Rhode Island | United States | |
| 121 | Local Institution | E. Providence | Rhode Island | United States | |
| 122 | Local Institution | Johnston | Rhode Island | United States | |
| 123 | Local Institution | Providence | Rhode Island | United States | |
| 124 | Local Institution | Anderson | South Carolina | United States | |
| 125 | Local Institution | Charleston | South Carolina | United States | |
| 126 | Local Institution | Greer | South Carolina | United States | |
| 127 | Local Institution | Simpsonville | South Carolina | United States | |
| 128 | Local Institution | Spartanburg | South Carolina | United States | |
| 129 | Local Institution | Bristol | Tennessee | United States | |
| 130 | Local Institution | Johnson City | Tennessee | United States | |
| 131 | Local Institution | Memphis | Tennessee | United States | |
| 132 | Local Institution | Austin | Texas | United States | |
| 133 | Local Institution | Corpus Christi | Texas | United States | |
| 134 | Local Institution | Dallas | Texas | United States | |
| 135 | Local Institution | Ft. Worth | Texas | United States | |
| 136 | Local Institution | Houston | Texas | United States | |
| 137 | Local Institution | Irving | Texas | United States | |
| 138 | Local Institution | Lake Jackson | Texas | United States | |
| 139 | Local Institution | San Antonio | Texas | United States | |
| 140 | Local Institution | Salt Lake City | Utah | United States | |
| 141 | Local Institution | Richmond | Virginia | United States | |
| 142 | Local Institution | Virginia Beach | Virginia | United States | |
| 143 | Local Institution | Edmonds | Washington | United States | |
| 144 | Local Institution | Federal Way | Washington | United States | |
| 145 | Local Institution | Renton | Washington | United States | |
| 146 | Local Institution | Spokane | Washington | United States | |
| 147 | Local Institution | Walla Walla | Washington | United States | |
| 148 | Local Institution | Madison | Wisconsin | United States | |
| 149 | Local Institution | New Berlin | Wisconsin | United States | |
| 150 | Local Institution | Chacabuco | Buenos Aires | Argentina | |
| 151 | Local Institution | Buenos Aires | Argentina | ||
| 152 | Local Institution | Mendoza | Argentina | ||
| 153 | Local Institution | Wollongong | New South Wales | Australia | |
| 154 | Local Institution | Fullerton | South Australia | Australia | |
| 155 | Local Institution | Box Hill | Victoria | Australia | |
| 156 | Local Institution | Fitzroy | Victoria | Australia | |
| 157 | Local Institution | Melbourne | Victoria | Australia | |
| 158 | Local Institution | Parkville | Victoria | Australia | |
| 159 | Local Institution | Perth | Western Australia | Australia | |
| 160 | Local Institution | Fortaleza | Ceara | Brazil | |
| 161 | Local Institution | Campo Grande | Mato Grosso | Brazil | |
| 162 | Local Institution | Belem | Para | Brazil | |
| 163 | Local Institution | Porto Alegre | Rio Grande Do Sul | Brazil | |
| 164 | Local Institution | Campinas | SAO Paulo | Brazil | |
| 165 | Local Institution | Marilia | Sao Paulo | Brazil | |
| 166 | Local Institution | S. J. Rio Preto | Sao Paulo | Brazil | |
| 167 | Local Institution | Taubate | Sao Paulo | Brazil | |
| 168 | Local Institution | Rio de Janeiro | Brazil | ||
| 169 | Local Institution | Sao Paulo | Brazil | ||
| 170 | Local Institution | Calgary | Alberta | Canada | |
| 171 | Local Institution | Edmonton | Alberta | Canada | |
| 172 | Local Institution | Winnipeg | Manitoba | Canada | |
| 173 | Local Institution | St. John's | Newfoundland and Labrador | Canada | |
| 174 | Local Institution | Ottawa | Ontario | Canada | |
| 175 | Local Institution | Drummonville | Quebec | Canada | |
| 176 | Local Institution | Longueuil | Quebec | Canada | |
| 177 | Local Institution | Ottawa | Quebec | Canada | |
| 178 | Local Institution | Sherbrooke | Quebec | Canada | |
| 179 | Local Institution | Brno | CZE | Czech Republic | |
| 180 | Local Institution | Ceske Budejovice | Czech Republic | ||
| 181 | Local Institution | Jihlava | Czech Republic | ||
| 182 | Local Institution | Liberec | Czech Republic | ||
| 183 | Local Institution | Prague | Czech Republic | ||
| 184 | Local Institution | Albens | France | ||
| 185 | Local Institution | Orthez | France | ||
| 186 | Local Institution | Rennes | France | ||
| 187 | Local Institution | Rosiers D'Egletons | France | ||
| 188 | Local Institution | Savigny en Veron | France | ||
| 189 | Local Institution | Strasbourg | France | ||
| 190 | Local Institution | Milano | Italy | ||
| 191 | Local Institution | Modena | Italy | ||
| 192 | Local Institution | Roma | Italy | ||
| 193 | Local Institution | Tijuana | Baja California | Mexico | |
| 194 | Local Institution | Mexico | Distrito Federal | Mexico | |
| 195 | Local Institution | Aguascalientes | Mexico | ||
| 196 | Local Institution | Distrito Federal | Mexico | ||
| 197 | Local Institution | Deventer | Netherlands | ||
| 198 | Local Institution | Ewijk | Netherlands | ||
| 199 | Local Institution | Hengelo | Netherlands | ||
| 200 | Local Institution | Lichtenvoorde | Netherlands | ||
| 201 | Local Institution | Losser | Netherlands | ||
| 202 | Local Institution | Ryswyk | Netherlands | ||
| 203 | Local Institution | Utrecht | Netherlands | ||
| 204 | Local Institution | Gorzow | Wielkopolski | Poland | |
| 205 | Local Institution | Stalowa | Wola | Poland | |
| 206 | Local Institution | Bydgoszcz | Poland | ||
| 207 | Local Institution | Lublin | Poland | ||
| 208 | Local Institution | Olsztyn | Poland | ||
| 209 | Local Institution | Szczecin | Poland | ||
| 210 | Local Institution | Warszawa | Poland | ||
| 211 | Local Institution | Wroclaw | Poland | ||
| 212 | Local Institution | Zabrze | Poland | ||
| 213 | Local Institution | Zielona Gora | Poland | ||
| 214 | Local Institution | Ponce | Puerto Rico | ||
| 215 | Local Institution | San Juan | Puerto Rico | ||
| 216 | Local Institution | Noordheuwel | Gauteng | South Africa | |
| 217 | Local Institution | Pretoria | Gauteng | South Africa | |
| 218 | Local Institution | Vanderbijlpark | Gauteng | South Africa | |
| 219 | Local Institution | George | Northern Cape | South Africa | |
| 220 | Local Institution | Tygerberg | Western Cape | South Africa | |
| 221 | Local Institution | Santiago | De Compostela | Spain | |
| 222 | Local Institution | Barcelona | ESP | Spain | |
| 223 | Local Institution | Cadiz | ESP | Spain | |
| 224 | Local Institution | Herston | Queensland | Spain | |
| 225 | Local Institution | Girona | Spain | ||
| 226 | Local Institution | Granada | Spain | ||
| 227 | Local Institution | Las Palmas de G.C. | Spain | ||
| 228 | Local Institution | Madrid | Spain | ||
| 229 | Local Institution | Oviedo | Spain | ||
| 230 | Local Institution | Gothenburg | Sweden | ||
| 231 | Local Institution | Helsingborg | Sweden | ||
| 232 | Local Institution | Linkoping | Sweden | ||
| 233 | Local Institution | Malmo | Sweden | ||
| 234 | Local Institution | Motala | Sweden | ||
| 235 | Local Institution | Savedalen | Sweden | ||
| 236 | Local Institution | Stockholm | Sweden | ||
| 237 | Local Institution | Vallingby | Sweden | ||
| 238 | Local Institution | Newtonabbey | Armach | United Kingdom | |
| 239 | Local Institution | Ely | Cambridgeshire | United Kingdom | |
| 240 | Local Institution | Soham | Cambridgeshire | United Kingdom | |
| 241 | Local Institution | Blantyre | Central | United Kingdom | |
| 242 | Local Institution | Chapelhall | Central | United Kingdom | |
| 243 | Local Institution | Paisley | Central | United Kingdom | |
| 244 | Local Institution | Riddrie | Central | United Kingdom | |
| 245 | Local Institution | Cumbernauld | Dumbartonshire | United Kingdom | |
| 246 | Local Institution | Moodiesburn | Dumbartonshire | United Kingdom | |
| 247 | Local Institution | Annan | Dumfries & Galloway | United Kingdom | |
| 248 | Local Institution | Dunscore | Dumfries & Galloway | United Kingdom | |
| 249 | Local Institution | Stranraer | Dumfries & Galloway | United Kingdom | |
| 250 | Local Institution | Moffat | Dumfriesshire | United Kingdom | |
| 251 | Local Institution | Bexhill-on-sea | East Sussex | United Kingdom | |
| 252 | Local Institution | High Valleyfield | Fife | United Kingdom | |
| 253 | Local Institution | Sunbury on Thames | Greater London | United Kingdom | |
| 254 | Local Institution | Caerleon | Gwent | United Kingdom | |
| 255 | Local Institution | Burnbank | Lanarkshire | United Kingdom | |
| 256 | Local Institution | Coatbridge | Lanarkshire | United Kingdom | |
| 257 | Local Institution | Edinburgh | Lothian | United Kingdom | |
| 258 | Local Institution | Hamilton | Lothian | United Kingdom | |
| 259 | Local Institution | Llandough | Mid Glamorgan | United Kingdom | |
| 260 | Local Institution | Pontyclun | Mid Glamorgan | United Kingdom | |
| 261 | Local Institution | Neilston | Renfrewshire | United Kingdom | |
| 262 | Local Institution | Paisley | Renfrewshire | United Kingdom | |
| 263 | Local Institution | Kilsyth | Stirlingshire | United Kingdom | |
| 264 | Local Institution | Lanarkshire | Strathclyde | United Kingdom | |
| 265 | Local Institution | East Horsley | Surrey | United Kingdom | |
| 266 | Local Institution | Cookstown | Tyrone | United Kingdom | |
| 267 | Local Institution | Atherstone | Warwickshire | United Kingdom | |
| 268 | Local Institution | Balsall Common | Warwickshire | United Kingdom | |
| 269 | Local Institution | Stratford Upon Avon | Warwickshire | United Kingdom | |
| 270 | Local Institution | Chelmsley wod | West Midlands | United Kingdom | |
| 271 | Local Institution | Chippenham | Wiltshire | United Kingdom | |
| 272 | Local Institution | Glasgow | United Kingdom |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00240383
Other Study ID Numbers:
- CV168-006
First Posted:
Oct 18, 2005
Last Update Posted:
Sep 14, 2010
Last Verified:
Jun 1, 2008