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
NCT ID: NCT00327015
Last Updated: 2015-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1306 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Saxagliptin and Metformin (A)
PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Saxagliptin and Metformin (B)
PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin
Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Saxagliptin and Placebo (C)
PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Placebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Metformin and Placebo (D)
PLUS open-label pioglitazone (as needed as rescue medication)
Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
Placebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Interventions
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Saxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Saxagliptin
Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
Placebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate blood sugar control
* No current treatment with other medications to lower blood sugar
Exclusion Criteria
* Pregnant or breast feeding
18 Years
77 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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East Bay Clinical Trial Center
Concord, California, United States
Encompass Clinical Research
Encinitas, California, United States
Community Clinical Trials
Orange, California, United States
Coastal Biomedical Research Inc
Santa Monica, California, United States
Encompass Clinical Research
Spring Valley, California, United States
St. Joseph'S Medical Associates
Stockton, California, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Florida Research Network, Llc
Gainesville, Florida, United States
Fpa Clinical Research
Kissimmee, Florida, United States
Emerald Coast Research Group
Marianna, Florida, United States
Baptist Diabetes Associates
Miami, Florida, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Adviso Medical Research, Llc
Chicago, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Physicians Research Group
Indianapolis, Indiana, United States
Professional Network Research Of Kansas
Wichita, Kansas, United States
Medical Arts Research Collaborative, Llc
Excelsior Springs, Missouri, United States
Nevada Alliance Against Diabetes
North Las Vegas, Nevada, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Durham Internal Medicine Assoc.
Durham, North Carolina, United States
Down East Medical Associates
Morehead City, North Carolina, United States
Midwest Regional Research, Inc.
Bellbrook, Ohio, United States
Massillon Family Practice
Massillon, Ohio, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, United States
Newark Physician Associates
Newark, Ohio, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Internal Medicine Of Greer
Greer, South Carolina, United States
Middle Tennessee Clinical Research
Fayetteville, Tennessee, United States
Frontier Clinical Research, Llc.
Memphis, Tennessee, United States
Capital Medical Clinic, Llp
Austin, Texas, United States
Endocrine Associates
Houston, Texas, United States
Advances In Health,Inc
Houston, Texas, United States
Juno Research, Llc
Houston, Texas, United States
Non Invasive Cardiovascular Pa
Houston, Texas, United States
Tiena Health Research
Irving, Texas, United States
Diabetes Center Of The Southwest
Midland, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
Pearland Primary Care Associates, Llp
Pearland, Texas, United States
Med-Cure Primary Care Physicians
Rosenberg, Texas, United States
Gsa Research
San Antonio, Texas, United States
Covenant Clinical Research, Pa
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
Seven Corners Medical Research Center
Falls Church, Virginia, United States
Salem Va Medical Ctr Research & Devlopment
Salem, Virginia, United States
Physicians Clinic Of Spokane
Spokane, Washington, United States
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Belgrano, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Chacabuco, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Morón, Buenos Aires, Argentina
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San Martín, Buenos Aires, Argentina
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San Pedro, Buenos Aires, Argentina
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Zárate, Buenos Aires, Argentina
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Mendoza, Mendoza Province, Argentina
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Salta, Salta Province, Argentina
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Salta, Salta Province, Argentina
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San Juan, San Juan Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Lanus Este, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Belém, Pará, Brazil
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Recife, Pernambuco, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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Marília, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Aschaffenburg, , Germany
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Bad, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Heidelberg, , Germany
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Künzing, , Germany
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Ludwigshafen, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Saarbrücken, , Germany
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Vellmar, , Germany
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Wangen, , Germany
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Eger, , Hungary
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Érd, , Hungary
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Gyula, , Hungary
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Szentes, , Hungary
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Panjagutta, Hyderabad, Andhra Pradesh, India
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Vasanth Nagar, Bangalore, India
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Bangalore, Karnataka, India
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Pune, Maharashtra, India
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Kandivili West, Mumbai, India
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Sarita Vihar, New Delhi, India
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Chennai, Tamil Nadu, India
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Bangalore, , India
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Chennai, , India
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Haryāna, , India
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Rajasthan, , India
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Rajasthan, , India
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Vellore, Tamilnadu, , India
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Catania, , Italy
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Milan, , Italy
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Perugia, , Italy
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Ravenna, , Italy
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Garza García, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Mérida, Yucatán, Mexico
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Cebu City, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Marikina City, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Gniewkowo, , Poland
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Gorzów Wielkopolski, , Poland
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Izabelin, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Michalow-Regionow, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Carolina, , Puerto Rico
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Ponce, , Puerto Rico
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Ponce, , Puerto Rico
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Rio Pieoras, , Puerto Rico
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
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Kemerovo, Russia, Russia
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Moscow, Russia, Russia
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Moscow, Russia, Russia
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Moscow, Russia, Russia
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Nizhny Novgorod, Russia, Russia
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Izhevsk, , Russia
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Kirov, , Russia
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Krasnodar, , Russia
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Krasnodar, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Perm, , Russia
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Rostov-on-Don, , Russia
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Rostov-on-Don, , Russia
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Saint Peterburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Tuymen, , Russia
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Vladimir, , Russia
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Volgograd, , Russia
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Volgograd, , Russia
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Yaroslaval, , Russia
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Yaroslavl, , Russia
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Dniepropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Ternopil, , Ukraine
Countries
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References
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Jadzinsky M, Pfutzner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039 Investigators. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab. 2009 Jun;11(6):611-22. doi: 10.1111/j.1463-1326.2009.01056.x.
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.
Pfutzner A, Paz-Pacheco E, Allen E, Frederich R, Chen R; CV181039 Investigators. Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes Metab. 2011 Jun;13(6):567-76. doi: 10.1111/j.1463-1326.2011.01385.x.
Other Identifiers
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CV181-039
Identifier Type: -
Identifier Source: org_study_id
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