Diabetes Mellitus II Clinical Trial
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
| Verified date | June 2008 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1260 |
| Est. completion date | June 2006 |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - 1. HbA1c > 7.0% and = 10.0% obtained at the Screening visit. - 2. Men and women, 18-70 years of age Established Type 2 diabetes Exclusion Criteria: - 1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months. - 2. 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. - 3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Chacabuco | Buenos Aires |
| Argentina | Local Institution | Mendoza | |
| Australia | Local Institution | Box Hill | Victoria |
| Australia | Local Institution | Fitzroy | Victoria |
| Australia | Local Institution | Fullerton | South Australia |
| Australia | Local Institution | Melbourne | Victoria |
| Australia | Local Institution | Parkville | Victoria |
| Australia | Local Institution | Perth | Western Australia |
| Australia | Local Institution | Wollongong | New South Wales |
| Brazil | Local Institution | Belem | Para |
| Brazil | Local Institution | Campinas | SAO Paulo |
| Brazil | Local Institution | Campo Grande | Mato Grosso |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Marilia | Sao Paulo |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | S. J. Rio Preto | Sao Paulo |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Taubate | Sao Paulo |
| Canada | Local Institution | Calgary | Alberta |
| Canada | Local Institution | Drummonville | Quebec |
| Canada | Local Institution | Edmonton | Alberta |
| Canada | Local Institution | Longueuil | Quebec |
| Canada | Local Institution | Ottawa | Quebec |
| Canada | Local Institution | Ottawa | Ontario |
| Canada | Local Institution | Sherbrooke | Quebec |
| Canada | Local Institution | St. John's | Newfoundland and Labrador |
| Canada | Local Institution | Winnipeg | Manitoba |
| Czech Republic | Local Institution | Brno | CZE |
| Czech Republic | Local Institution | Ceske Budejovice | |
| Czech Republic | Local Institution | Jihlava | |
| Czech Republic | Local Institution | Liberec | |
| Czech Republic | Local Institution | Prague | |
| France | Local Institution | Albens | |
| France | Local Institution | Orthez | |
| France | Local Institution | Rennes | |
| France | Local Institution | Rosiers D'Egletons | |
| France | Local Institution | Savigny en Veron | |
| France | Local Institution | Strasbourg | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Modena | |
| Italy | Local Institution | Roma | |
| Mexico | Local Institution | Aguascalientes | |
| Mexico | Local Institution | Distrito Federal | |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution | Tijuana | Baja California |
| Netherlands | Local Institution | Deventer | |
| Netherlands | Local Institution | Ewijk | |
| Netherlands | Local Institution | Hengelo | |
| Netherlands | Local Institution | Lichtenvoorde | |
| Netherlands | Local Institution | Losser | |
| Netherlands | Local Institution | Ryswyk | |
| Netherlands | Local Institution | Utrecht | |
| Poland | Local Institution | Bydgoszcz | |
| Poland | Local Institution | Gorzow | Wielkopolski |
| Poland | Local Institution | Lublin | |
| Poland | Local Institution | Olsztyn | |
| Poland | Local Institution | Stalowa | Wola |
| Poland | Local Institution | Szczecin | |
| Poland | Local Institution | Warszawa | |
| Poland | Local Institution | Wroclaw | |
| Poland | Local Institution | Zabrze | |
| Poland | Local Institution | Zielona Gora | |
| Puerto Rico | Local Institution | Ponce | |
| Puerto Rico | Local Institution | San Juan | |
| South Africa | Local Institution | George | Northern Cape |
| South Africa | Local Institution | Noordheuwel | Gauteng |
| South Africa | Local Institution | Pretoria | Gauteng |
| South Africa | Local Institution | Tygerberg | Western Cape |
| South Africa | Local Institution | Vanderbijlpark | Gauteng |
| Spain | Local Institution | Barcelona | ESP |
| Spain | Local Institution | Cadiz | ESP |
| Spain | Local Institution | Girona | |
| Spain | Local Institution | Granada | |
| Spain | Local Institution | Herston | Queensland |
| Spain | Local Institution | Las Palmas de G.C. | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Oviedo | |
| Spain | Local Institution | Santiago | De Compostela |
| Sweden | Local Institution | Gothenburg | |
| Sweden | Local Institution | Helsingborg | |
| Sweden | Local Institution | Linkoping | |
| Sweden | Local Institution | Malmo | |
| Sweden | Local Institution | Motala | |
| Sweden | Local Institution | Savedalen | |
| Sweden | Local Institution | Stockholm | |
| Sweden | Local Institution | Vallingby | |
| United Kingdom | Local Institution | Annan | Dumfries & Galloway |
| United Kingdom | Local Institution | Atherstone | Warwickshire |
| United Kingdom | Local Institution | Balsall Common | Warwickshire |
| United Kingdom | Local Institution | Bexhill-on-sea | East Sussex |
| United Kingdom | Local Institution | Blantyre | Central |
| United Kingdom | Local Institution | Burnbank | Lanarkshire |
| United Kingdom | Local Institution | Caerleon | Gwent |
| United Kingdom | Local Institution | Chapelhall | Central |
| United Kingdom | Local Institution | Chelmsley wod | West Midlands |
| United Kingdom | Local Institution | Chippenham | Wiltshire |
| United Kingdom | Local Institution | Coatbridge | Lanarkshire |
| United Kingdom | Local Institution | Cookstown | Tyrone |
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| United Kingdom | Local Institution | Dunscore | Dumfries & Galloway |
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| United Kingdom | Local Institution | Kilsyth | Stirlingshire |
| United Kingdom | Local Institution | Lanarkshire | Strathclyde |
| United Kingdom | Local Institution | Llandough | Mid Glamorgan |
| United Kingdom | Local Institution | Moffat | Dumfriesshire |
| United Kingdom | Local Institution | Moodiesburn | Dumbartonshire |
| United Kingdom | Local Institution | Neilston | Renfrewshire |
| United Kingdom | Local Institution | Newtonabbey | Armach |
| United Kingdom | Local Institution | Paisley | Central |
| United Kingdom | Local Institution | Paisley | Renfrewshire |
| United Kingdom | Local Institution | Pontyclun | Mid Glamorgan |
| United Kingdom | Local Institution | Riddrie | Central |
| United Kingdom | Local Institution | Soham | Cambridgeshire |
| United Kingdom | Local Institution | Stranraer | Dumfries & Galloway |
| United Kingdom | Local Institution | Stratford Upon Avon | Warwickshire |
| United Kingdom | Local Institution | Sunbury on Thames | Greater London |
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| United States | Local Institution | New Britain | Connecticut |
| United States | Local Institution | New Hyde Park | New York |
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| United States | Local Institution | Olive Branch | Mississippi |
| United States | Local Institution | Omaha | Nebraska |
| United States | Local Institution | Orange | California |
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| United States | Local Institution | San Antonio | Texas |
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| United States | Local Institution | Santa Barbara | California |
| United States | Local Institution | Shawnee Mission | Kansas |
| United States | Local Institution | Simpsonville | South Carolina |
| United States | Local Institution | Slidell | Louisiana |
| United States | Local Institution | Spartanburg | South Carolina |
| United States | Local Institution | Spokane | Washington |
| United States | Local Institution | Spring Valley | California |
| United States | Local Institution | Springfield | Massachusetts |
| United States | Local Institution | Springfield | Missouri |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | St. Petersburg | Florida |
| United States | Local Institution | Swansea | Massachusetts |
| United States | Local Institution | Tallahassee | Florida |
| United States | Local Institution | Tamarac | Florida |
| United States | Local Institution | Tempe | Arizona |
| United States | Local Institution | Titusville | Florida |
| United States | Local Institution | Toms River | New Jersey |
| United States | Local Institution | Tucson | Arizona |
| United States | Local Institution | Tulsa | Oklahoma |
| United States | Local Institution | Tustin | California |
| United States | Local Institution | Vernon Hills | Illinois |
| United States | Local Institution | Virginia Beach | Virginia |
| United States | Local Institution | Walla Walla | Washington |
| United States | Local Institution | Walnut Creek | California |
| United States | Local Institution | West Palm Beach | Florida |
| United States | Local Institution | Wheat Ridge | Colorado |
| United States | Local Institution | Wichita | Kansas |
| United States | Local Institution | Worcester | Massachusetts |
| United States | Local Institution | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Brazil, Canada, Czech Republic, France, Italy, Mexico, Netherlands, Poland, Puerto Rico, South Africa, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |