PPAR - Combination With Metformin
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00162240
Collaborator
(none)
534
203
11
2.6
0.2
Study Details
Study Description
Brief Summary
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study Start Date
:
Jun 1, 2003
Actual Study Completion Date
:
May 1, 2004
Outcome Measures
Primary Outcome Measures
- compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin []
Secondary Outcome Measures
- change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 Diabetes
-
HbA1c > - 7.0% and < - 10.0 %
-
Mean serum triglyceride < - 600 mg/dL
-
Body mass index < - 41 kg/m2
-
Fasting c-peptide > - 1.0 ng/mL
Exclusion Criteria:
-
History of myocardial infarction (MI)
-
coronary angioplasty or bypass graft(s)
-
valvular disease or repair
-
unstable angina pectoris
-
transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
-
Congestive heart failure NYHA Class III and IV
-
Uncontrolled hypertension
-
History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
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 | Haleyville | Alabama | United States | |
| 4 | Local Institution | Mobile | Alabama | United States | |
| 5 | Local Institution | Mesa | Arizona | United States | |
| 6 | Local Institution | Phoenix | Arizona | United States | |
| 7 | Local Institution | Tucson | Arizona | United States | |
| 8 | Local Institution | Fayette | Arkansas | United States | |
| 9 | Local Institution | Little Rock | Arkansas | United States | |
| 10 | Local Institution | Concord | California | United States | |
| 11 | Local Institution | Fountain Valley | California | United States | |
| 12 | Local Institution | La Jolla | California | United States | |
| 13 | Local Institution | Los Angeles | California | United States | |
| 14 | Local Institution | Los Gatos | California | United States | |
| 15 | Local Institution | Mission Viejo | California | United States | |
| 16 | Local Institution | Pasadena | California | United States | |
| 17 | Local Institution | Rolling Hills Estate | California | United States | |
| 18 | Local Institution | Roseville | California | United States | |
| 19 | Local Institution | San Diego | California | United States | |
| 20 | Local Institution | Spring Valley | California | United States | |
| 21 | Local Institution | Walnut Creek | California | United States | |
| 22 | Local Institution | Colorado Springs | Colorado | United States | |
| 23 | Local Institution | Denver | Colorado | United States | |
| 24 | Local Institution | Littleton | Colorado | United States | |
| 25 | Local Institution | Loveland | Colorado | United States | |
| 26 | Local Institution | Wheat Ridge | Colorado | United States | |
| 27 | Local Institution | New Britain | Connecticut | United States | |
| 28 | Local Institution | Newark | Delaware | United States | |
| 29 | Local Institution | Wilmington | Delaware | United States | |
| 30 | Local Institution | Chipley | Florida | United States | |
| 31 | Local Institution | Cooper City | Florida | United States | |
| 32 | Local Institution | Kissimmee | Florida | United States | |
| 33 | Local Institution | Melbourne | Florida | United States | |
| 34 | Local Institution | Miami | Florida | United States | |
| 35 | Local Institution | New Port Richey | Florida | United States | |
| 36 | Local Institution | Ocala | Florida | United States | |
| 37 | Local Institution | Orlando | Florida | United States | |
| 38 | Local Institution | Winter Park | Florida | United States | |
| 39 | Local Institution | Columbus | Georgia | United States | |
| 40 | Local Institution | Dunwoody | Georgia | United States | |
| 41 | Local Institution | Honolulu | Hawaii | United States | |
| 42 | Local Institution | Overland Park | Kansas | United States | |
| 43 | Local Institution | Shawnee Mission | Kansas | United States | |
| 44 | Local Institution | Wichita | Kansas | United States | |
| 45 | Local Institution | Louisville | Kentucky | United States | |
| 46 | Local Institution | Richmond | Kentucky | United States | |
| 47 | Local Institution | SLidell | Louisiana | United States | |
| 48 | Local Institution | Chester | Maryland | United States | |
| 49 | Local Institution | Silver Spring | Maryland | United States | |
| 50 | Local Institution | Ayer | Massachusetts | United States | |
| 51 | Local Institution | Springfield | Massachusetts | United States | |
| 52 | Local Institution | Sudbury | Massachusetts | United States | |
| 53 | Local Institution | Lansing | Michigan | United States | |
| 54 | Local Institution | Arden Hills | Minnesota | United States | |
| 55 | Local Institution | Gulfport | Mississippi | United States | |
| 56 | Local Institution | Olive Branch | Mississippi | United States | |
| 57 | Local Institution | Rolling Fork | Mississippi | United States | |
| 58 | Local Institution | Excelsior Springs | Missouri | United States | |
| 59 | Local Institution | Kansas City | Missouri | United States | |
| 60 | Local Institution | Springfield | Missouri | United States | |
| 61 | Local Institution | St. Peters | Missouri | United States | |
| 62 | Local Institution | St.Louis | Missouri | United States | |
| 63 | Local Institution | Omaha | Nebraska | United States | |
| 64 | Local Institution | Toms River | New Jersey | United States | |
| 65 | Local Institution | Albuquerque | New Mexico | United States | |
| 66 | Local Institution | Buffalo | New York | United States | |
| 67 | Local Institution | New Hyde Park | New York | United States | |
| 68 | Local Institution | West Seneca | New York | United States | |
| 69 | Local Institution | Westfield | New York | United States | |
| 70 | Local Institution | Charlotte | North Carolina | United States | |
| 71 | Local Institution | Durham | North Carolina | United States | |
| 72 | Local Institution | Greensboro | North Carolina | United States | |
| 73 | Local Institution | Greenville | North Carolina | United States | |
| 74 | Local Institution | Hickory | North Carolina | United States | |
| 75 | Local Institution | High Point | North Carolina | United States | |
| 76 | Local Institution | Huntersville | North Carolina | United States | |
| 77 | Local Institution | Salisbury | North Carolina | United States | |
| 78 | Local Institution | Wilmington | North Carolina | United States | |
| 79 | Local Institution | Winston Salem | North Carolina | United States | |
| 80 | Local Institution | Cincinnati | Ohio | United States | |
| 81 | Local Institution | Oklahoma City | Oklahoma | United States | |
| 82 | Local Institution | Tulsa | Oklahoma | United States | |
| 83 | Local Institution | Corvallis | Oregon | United States | |
| 84 | Local Institution | Eugene | Oregon | United States | |
| 85 | Local Institution | Hillsboro | Oregon | United States | |
| 86 | Local Institution | Portland | Oregon | United States | |
| 87 | Local Institution | Philadelphia | Pennsylvania | United States | |
| 88 | Local Institution | Warminster | Pennsylvania | United States | |
| 89 | Local Institution | Cranston | Rhode Island | United States | |
| 90 | Local Institution | Duncan | South Carolina | United States | |
| 91 | Local Institution | Greer | South Carolina | United States | |
| 92 | Local Institution | Simpsonville | South Carolina | United States | |
| 93 | Local Institution | Bristol | Tennessee | United States | |
| 94 | Local Institution | Kingsport | Tennessee | United States | |
| 95 | Local Institution | Memphis | Tennessee | United States | |
| 96 | Local Institution | Dallas | Texas | United States | |
| 97 | Local Institution | Houston | Texas | United States | |
| 98 | Local Institution | Irving | Texas | United States | |
| 99 | Local Institution | Lake Jackson | Texas | United States | |
| 100 | Local Institution | Lubbock | Texas | United States | |
| 101 | Local Institution | San Antonio | Texas | United States | |
| 102 | Local Institution | Salt Lake City | Utah | United States | |
| 103 | Local Institution | Springfield | Virginia | United States | |
| 104 | Local Institution | Virginia Beach | Virginia | United States | |
| 105 | Local Institution | Olympia | Washington | United States | |
| 106 | Local Institution | Renton | Washington | United States | |
| 107 | Local Institution | Spokane | Washington | United States | |
| 108 | Local Institution | Milwaukee | Wisconsin | United States | |
| 109 | Local Institution | Bahia Blanca | Buenos Aires | Argentina | |
| 110 | Local Institution | Buenos Aires | Capital Federal | Argentina | |
| 111 | Local Institution | Buenos Aires | Argentina | ||
| 112 | Local Institution | Cordoba | Argentina | ||
| 113 | Local Institution | Mendoza | Argentina | ||
| 114 | Local Institution | Canberra | New South Wales | Australia | |
| 115 | Local Institution | Sydney | New South Wales | Australia | |
| 116 | Local Institution | Wollongong | New South Wales | Australia | |
| 117 | Local Institution | Brisbane | Queensland | Australia | |
| 118 | Local Institution | Meadowbrook | Queensland | Australia | |
| 119 | Local Institution | Perth | Western Australia | Australia | |
| 120 | Local Institution | Curitiba | Parana | Brazil | |
| 121 | Local Institution | Belem | Para | Brazil | |
| 122 | Local Institution | Porto Alegre | Rio Grande do Sul | Brazil | |
| 123 | Local Institution | Calgary | Alberta | Canada | |
| 124 | Local Institution | Coquitlam | British Columbia | Canada | |
| 125 | Local Institution | Winnipeg | Manitoba | Canada | |
| 126 | Local Institution | Manuels | Newfoundland and Labrador | Canada | |
| 127 | Local Institution | ST. John's | Newfoundland and Labrador | Canada | |
| 128 | Local Institution | Halifax | Nova Scotia | Canada | |
| 129 | Local Institution | Oakville | Ontario | Canada | |
| 130 | Local Institution | Ottawa | Ontario | Canada | |
| 131 | Local Institution | Thornhill | Ontario | Canada | |
| 132 | Local Institution | Toronto | Ontario | Canada | |
| 133 | Local Institution | Chicoutimi | Quebec | Canada | |
| 134 | Local Institution | Fleurimont | Quebec | Canada | |
| 135 | Local Institution | Granby | Quebec | Canada | |
| 136 | Local Institution | Laval | Quebec | Canada | |
| 137 | Local Institution | Longueuil | Quebec | Canada | |
| 138 | Local Institution | Montreal | Quebec | Canada | |
| 139 | Local Institution | Pointe-Claire | Quebec | Canada | |
| 140 | Local Institution | Sherbrooke | Quebec | Canada | |
| 141 | Local Institution | Saskatoon | Saskatchewan | Canada | |
| 142 | Local Institution | Albens | France | ||
| 143 | Local Institution | Broglie | France | ||
| 144 | Local Institution | Chartres | France | ||
| 145 | Local Institution | Fabregues | France | ||
| 146 | Local Institution | Gemenos | France | ||
| 147 | Local Institution | Husseren Wesserling | France | ||
| 148 | Local Institution | Labarthe Sur Leze | France | ||
| 149 | Local Institution | Rosiers D'Egletons | France | ||
| 150 | Local Institution | Seoul | Korea, Republic of | ||
| 151 | Local Institution | Tijuana | Baja California | Mexico | |
| 152 | Local Institution | Mexico | Distrito Federal | Mexico | |
| 153 | Local Institution | Leon | Guanajuato | Mexico | |
| 154 | Local Institution | Cuernavaca | Morelos | Mexico | |
| 155 | Local Institution | Monterrey | Nuevo Leon | Mexico | |
| 156 | Local Institution | Merida | Yucatan | Mexico | |
| 157 | Local Institution | Distrito Federal | Mexico | ||
| 158 | Local Institution | Durango | Mexico | ||
| 159 | Local Institution | Arequipa | Peru | ||
| 160 | Local Institution | Lima | Peru | ||
| 161 | Local Institution | Anasco | Puerto Rico | ||
| 162 | Local Institution | Carolina | Puerto Rico | ||
| 163 | Local Institution | Guaynabo | Puerto Rico | ||
| 164 | Local Institution | Ponce | Puerto Rico | ||
| 165 | Local Institution | Rio Piedras | Puerto Rico | ||
| 166 | Local Institution | Angelholm | Sweden | ||
| 167 | Local Institution | Bjuv | Sweden | ||
| 168 | Local Institution | Enskede | Sweden | ||
| 169 | Local Institution | Farsta | Sweden | ||
| 170 | Local Institution | Gothenburg | Sweden | ||
| 171 | Local Institution | Helsingborg | Sweden | ||
| 172 | Local Institution | Jarfalla | Sweden | ||
| 173 | Local Institution | Landskrona | Sweden | ||
| 174 | Local Institution | Leksand | Sweden | ||
| 175 | Local Institution | Linkoping | Sweden | ||
| 176 | Local Institution | Malmo | Sweden | ||
| 177 | Local Institution | Odeshog | Sweden | ||
| 178 | Local Institution | Savedalen | Sweden | ||
| 179 | Local Institution | Sjuntorp | Sweden | ||
| 180 | Local Institution | Stockholm | Sweden | ||
| 181 | Local Institution | Trollhattan | Sweden | ||
| 182 | Local Institution | Vallingby | Sweden | ||
| 183 | Local Institution | Carrickfergus | Antrim | United Kingdom | |
| 184 | Local Institution | Soham | Cambridgeshire | United Kingdom | |
| 185 | Local Institution | Doncaster | Derbyshire | United Kingdom | |
| 186 | Local Institution | Paignton | Devon | United Kingdom | |
| 187 | Local Institution | Bangor | Down | United Kingdom | |
| 188 | Local Institution | Downpatrick | Down | United Kingdom | |
| 189 | Local Institution | Bexhill-On-Sea | East Sussex | United Kingdom | |
| 190 | Local Institution | High Valleyfield | Fife | United Kingdom | |
| 191 | Local Institution | Sunbury on Thames | Greater London | United Kingdom | |
| 192 | Local Institution | Aldershot | Hampshire | United Kingdom | |
| 193 | Local Institution | Glasgow | Lanarkshire | United Kingdom | |
| 194 | Local Institution | Blackpool | Lancashire | United Kingdom | |
| 195 | Local Institution | Farnworth | Lancashire | United Kingdom | |
| 196 | Local Institution | Harrow | Middlesex | United Kingdom | |
| 197 | Local Institution | Doncaster | North Yorkshire | United Kingdom | |
| 198 | Local Institution | Hastings | Sussex | United Kingdom | |
| 199 | Local Institution | Atherstone | Warwickshire | United Kingdom | |
| 200 | Local Institution | Nuneaton | Warwickshire | United Kingdom | |
| 201 | Local Institution | Bath | Wiltshire | United Kingdom | |
| 202 | Local Institution | Inkberrow | Worcestershire | United Kingdom | |
| 203 | Local Institution | Swan Lake | 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:
NCT00162240
Other Study ID Numbers:
- CV168-022
First Posted:
Sep 13, 2005
Last Update Posted:
Apr 27, 2012
Last Verified:
Apr 1, 2012
Keywords provided by ,
,
Additional relevant MeSH terms: