A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Condition(s) targeted: Diabetes

Intervention: Saxagliptin and Metformin (Drug); Saxagliptin and Metformin (Drug); Saxagliptin and Placebo (Drug); Metformin and Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone.

Official title: A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Mean reduction in baseline A1C values after 24 weeks of treatment

Secondary outcome:

Subjects achieving a glycemic response defined as A1C < 7.0%

Change from baseline in the fasting plasma glucose

Change from baseline in the area under the curve (AUC) for postprandial glucose (PPG) response

Subjects requiring rescue for failing to achieve glycemic targets or the need for discontinuation due to lack of efficacy

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Inadequate blood sugar control

- No current treatment with other medications to lower blood sugar

Exclusion Criteria:

- Major heart, liver or kidney problems

- Pregnant or breast feeding

Local Institution, Buenos Aires C1408INH, Argentina

Local Institution, Buenos Aires C1505CWB, Argentina

Local Institution, Buenos Aires C1425AGC, Argentina

Local Institution, Buenos Aires C1117ABH, Argentina

Local Institution, Buenos Aires 1121, Argentina

Local Institution, Buenos Aires B7602CBM, Argentina

Local Institution, Mendoza CP5500, Argentina

Local Institution, Salta A4400EMI, Argentina

Local Institution, Salta 4406, Argentina

Local Institution, San Juan 5400, Argentina

Local Institution, Sao Paulo 01244, Brazil

Local Institution, Sao Paulo 04020, Brazil

Local Institution, Heidelberg 69120, Germany

Local Institution, Wangen Im Allgau 88239, Germany

Local Institution, Vellmar 34246, Germany

Local Institution, Magdeburg 39112, Germany

Local Institution, Mannheim 68161, Germany

Local Institution, Duisburg 47051, Germany

Local Institution, Saarbrücken 66119, Germany

Local Institution, Ludwigshafen 67073, Germany

Local Institution, Mainz 55116, Germany

Local Institution, Bad 37431, Germany

Local Institution, Aschaffenburg 63739, Germany

Local Institution, Kuenzing 94550, Germany

Local Institution, Dresden O1219, Germany

Local Institution, Dresden 01307, Germany

Local Institution, Szigetvár 7900, Hungary

Local Institution, Eger 3300, Hungary

Local Institution, Szentes 6600, Hungary

Local Institution, Gyula 5700, Hungary

Local Institution, Érd 2030, Hungary

Local Institution, Bangalore 560054, India

Local Institution, Vellore, Tamilnadu 632004, India

Local Institution, Chennai 680004, India

Local Institution, Haryana 132001, India

Local Institution, Rajasthan 302001, India

Local Institution, Rajasthan 334 003, India

Local Institution, Milano 20132, Italy

Local Institution, Catania 20099, Italy

Local Institution, Ravenna 48100, Italy

Local Institution, Perugia 06124, Italy

Local Institution, Genova 16132, Italy

Local Institution, Aguascalientes 20230, Mexico

Local Institution, Aguascalientes 20232, Mexico

Local Institution, Cebu City 6000, Philippines

Local Institution, Manila City 1000, Philippines

Local Institution, Marikina City 1800, Philippines

Local Institution, Quezon City 1100, Philippines

Local Institution, Cebu City 6000, Philippines

Local Institution, Pasig City 1605, Philippines

Local Institution, Cebu City 6000, Philippines

Local Institution, Iloilo City 5000, Philippines

Local Institution, Krakow 31-159, Poland

Local Institution, Warszawa 03-563, Poland

Local Institution, Wroclaw 50-127, Poland

Local Institution, Izabelin 05-080, Poland

Local Institution, Michalow-Regionow 05-119, Poland

Local Institution, Gorzow Wielkopolski 66-400, Poland

Local Institution, Zabrze 41-800, Poland

Local Institution, Gniewkowo 88-140, Poland

Local Institution, Lublin 20-538, Poland

Local Institution, Rio Pieoras 00926, Puerto Rico

Local Institution, Carolina 00983, Puerto Rico

Local Institution, Ponce 00717, Puerto Rico

Local Institution, San Juan 00920, Puerto Rico

Local Institution, San Juan 00909, Puerto Rico

Local Institution, Ponce 00716, Puerto Rico

Local Institution, Saratov 410024, Russian Federation

Local Institution, Saratov 410028, Russian Federation

Local Institution, Moscow 123423, Russian Federation

Local Institution, Moscow 127486, Russian Federation

Local Institution, Moscow 125315, Russian Federation

Local Institution, Moscow 11992, Russian Federation

Local Institution, Moscow 115093, Russian Federation

Local Institution, Moscow 119034, Russian Federation

Local Institution, Moscow 129119, Russian Federation

Local Institution, Moscow 129327, Russian Federation

Local Institution, Moscow 129010, Russian Federation

Local Institution, St. Peterburg 195257, Russian Federation

Local Institution, St.Petersburg 192177, Russian Federation

Local Institution, St.Petersburg 194354, Russian Federation

Local Institution, St. Petersburg 195112, Russian Federation

Local Institution, Tuymen 625023, Russian Federation

Local Institution, Perm 614095, Russian Federation

Local Institution, Rostov-Na-Donu 344029, Russian Federation

Local Institution, Rostov-Na-Donu 344022, Russian Federation

Local Institution, Yaroslavl 150003, Russian Federation

Local Institution, Yaroslaval 150003, Russian Federation

Local Institution, Kursk 305035, Russian Federation

Local Institution, Krasnodar 350042, Russian Federation

Local Institution, Krasnodar 350012, Russian Federation

Local Institution, Izhevsk 426000, Russian Federation

Local Institution, Novosibirsk 630087, Russian Federation

Local Institution, Novosibirsk 630047, Russian Federation

Local Institution, St-Petersburg 197022, Russian Federation

Local Institution, Volgograd 400107, Russian Federation

Local Institution, Saratov 410054, Russian Federation

Local Institution, Saint Petersburg 198013, Russian Federation

Local Institution, Smolensk 214018, Russian Federation

Local Institution, Nizhniy Novgorod 603126, Russian Federation

Local Institution, Moscow 115280, Russian Federation

Local Institution, Moscow 117292, Russian Federation

Local Institution, Saratov 410053, Russian Federation

Local Institution, St. Petersburg 193312, Russian Federation

Local Institution, Moscow 127644, Russian Federation

Local Institution, St.Petersburg 195176, Russian Federation

Local Institution, Kirov 610030, Russian Federation

Local Institution, Volgograd 400001, Russian Federation

Local Institution, Moscow 105229, Russian Federation

Local Institution, St Petersburg 193015, Russian Federation

Local Institution, St Petersburg 193015, Russian Federation

Local Institution, St Petersburg 193015, Russian Federation

Local Institution, St. Petersburg 197198, Russian Federation

Local Institution, St.Petersburg 191119, Russian Federation

Local Institution, Vladimir 600023, Russian Federation

Local Institution, Odessa 65025, Ukraine

Local Institution, Lviv 79013, Ukraine

Local Institution, Dniepropetrovsk 49044, Ukraine

Local Institution, Kharkiv 61039, Ukraine

Local Institution, Kyiv 4050, Ukraine

Local Institution, Kyiv 03680, Ukraine

Local Institution, Ternopil 46001, Ukraine

Local Institution, Lviv 790015, Ukraine

Local Institution, Kharkiv 61176, Ukraine

Local Institution, Lutsk 43024, Ukraine

Local Institution, Panjagutta, Hyderabad, Andhra Pradesh 500082, India

Local Institution, Vasanth Nagar, Bangalore 560052, India

Local Institution, Moron, Buenos Aires B1708IFF, Argentina

Local Institution, San Martin, Buenos Aires CP1405, Argentina

Local Institution, Belgrano, Buenos Aires C1426EGP, Argentina

Local Institution, Chacabuco, Buenos Aires 6740, Argentina

Local Institution, La Plata, Buenos Aires B1902COS, Argentina

Local Institution, Capital Federal, Buenos Aires C1406GWY, Argentina

Local Institution, Capital Federal, Buenos Aires 1221, Argentina

Local Institution, Zarate, Buenos Aires 2800, Argentina

Local Institution, San Pedro, Buenos Aires B2930DGO, Argentina

Coastal Biomedical Research Inc, Santa Monica, California 90404, United States

East Bay Clinical Trial Center, Concord, California 94520, United States

Encompass Clinical Research, Encinitas, California 92024, United States

St. Joseph'S Medical Associates, Stockton, California 95204, United States

Encompass Clinical Research, Spring Valley, California 91978, United States

Community Clinical Trials, Orange, California 92868, United States

Local Institution, Fortaleza, Ceara 60021, Brazil

Local Institution, Fortaleza, Ceara 60430, Brazil

Local Institution, Mexico, Distrito Federal 06700, Mexico

Florida Research Network, Llc, Gainesville, Florida 32605, United States

Fpa Clinical Research, Kissimmee, Florida 34741, United States

Clinical Therapeutics Corporation, Coral Gables, Florida 33134, United States

Baptist Diabetes Associates, Miami, Florida 33156, United States

Emerald Coast Research Group, Marianna, Florida 32446, United States

Middle Georgia Drug Study Center, Llc, Perry, Georgia 31069, United States

Local Institution, Goiania, Goias 74110, Brazil

Cedar Crosse Research Center, Chicago, Illinois 60607, United States

Adviso Medical Research, Llc, Chicago, Illinois 60617, United States

Deerbrook Medical Associates, Vernon Hills, Illinois 60061, United States

Physicians Research Group, Indianapolis, Indiana 46250, United States

Local Institution, Guadalajara, Jalisco 45200, Mexico

Local Institution, Guadalajara, Jalisco 44340, Mexico

Local Institution, Guadalajara, Jalisco 44670, Mexico

Local Institution, Guadalajara, Jalisco 44650, Mexico

Local Institution, Guadalajara, Jalisco 45030, Mexico

Professional Network Research Of Kansas, Wichita, Kansas 67203, United States

Local Institution, Bangalore, Karnataka 560010, India

Local Institution, Pune, Maharashtra 411011, India

Medical Arts Research Collaborative, Llc, Excelsior Springs, Missouri 64024, United States

Local Institution, Cuernavaca, Morelos 62250, Mexico

Local Institution, Kandivili West, Mumbai 400067, India

Nevada Alliance Against Diabetes, N. Las Vegas, Nevada 89030, United States

Local Institution, Sarita Vihar, New Delhi 110076, India

Metrolina Medical Research, Charlotte, North Carolina 28209, United States

Durham Internal Medicine Assoc., Durham, North Carolina 27704, United States

Down East Medical Associates, Morehead City, North Carolina 28557, United States

Local Institution, Monterrey, Nuevo Leon 64460, Mexico

Local Institution, Garza Garcia, Nuevo Leon 66260, Mexico

Local Institution, Monterrey, Nuevo Leon 64020, Mexico

Local Institution, Monterrey, Nuevo Leon 64570, Mexico

Your Diabetes Endocrine Nutrition Group, Mentor, Ohio 44060, United States

Massillon Family Practice, Massillon, Ohio 44646, United States

Midwest Regional Research, Inc., Bellbrook, Ohio 45305, United States

Newark Physician Associates, Newark, Ohio 43055, United States

Local Institution, Belem, Para 66073, Brazil

Local Institution, Recife, Pe 52051, Brazil

Preferred Primary Care Physicians, Uniontown, Pennsylvania 15401, United States

Safe Harbor Clinical Research, E. Providence, Rhode Island 02914, United States

Local Institution, Porto Alegre, Rio Grande Do Sul 90035, Brazil

Local Institution, Nizhniy Novgorod, Russia 603018, Russian Federation

Local Institution, Moscow, Russia 125299, Russian Federation

Local Institution, Moscow, Russia 123056, Russian Federation

Local Institution, Kemerovo, Russia 650066, Russian Federation

Local Institution, Moscow, Russia 117593, Russian Federation

Local Institution, Rosario, Santa Fe CP2000, Argentina

Local Institution, Marília, Sao Paulo 17519, Brazil

Local Institution, Campinas, Sao Paulo 13059, Brazil

Local Institution, Campinas, Sao Paulo 13059, Brazil

Internal Medicine Of Greer, Greer, South Carolina 29651, United States

Local Institution, Chennai, Tamil Nadu 680086, India

Middle Tennessee Clinical Research, Fayetteville, Tennessee 37334, United States

Frontier Clinical Research, Llc., Memphis, Tennessee 38103, United States

Diabetes Center Of The Southwest, Midland, Texas 79705, United States

Hill Country Medical Associates, New Braunfels, Texas 78130, United States

Pearland Primary Care Associates, Llp, Pearland, Texas 77584, United States

Med-Cure Primary Care Physicians, Rosenberg, Texas 77471, United States

Gsa Research, San Antonio, Texas 78213, United States

Juno Research, Llc, Houston, Texas 77036, United States

Endocrine Associates, Houston, Texas 77004, United States

Tiena Health Research, Irving, Texas 75039, United States

Covenant Clinical Research, Pa, San Antonio, Texas 78229, United States

Capital Medical Clinic, Llp, Austin, Texas 78705, United States

Advances In Health,Inc, Houston, Texas 77030, United States

Non Invasive Cardiovascular Pa, Houston, Texas 77074, United States

S.A.M. Clinical Research Center, San Antonio, Texas 78229, United States

Local Institution, Lanus Este, Tucuman 1824, Argentina

Salem Va Medical Ctr Research & Devlopment, Salem, Virginia 24153, United States

Seven Corners Medical Research Center, Falls Church, Virginia 22044, United States

Physicians Clinic Of Spokane, Spokane, Washington 99204, United States

Local Institution, Merida, Yucatan 97070, Mexico

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: May 2006
Ending date: November 2007
Last updated: April 28, 2008