18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT ID: NCT00666458
Last Updated: 2010-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
822 participants
INTERVENTIONAL
2008-04-30
2009-03-31
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
QUADRUPLE
Study Groups
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1
saxagliptin add-on to metformin
saxagliptin
tablet, per oral, once daily
2
sitagliptin add-on to metformin
sitagliptin
capsule, per oral, once daily
Interventions
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saxagliptin
tablet, per oral, once daily
sitagliptin
capsule, per oral, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks
Exclusion Criteria
* Insulin therapy within one year
* Previous treatment with DPP-4 inhibitor
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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André Scheen, Professor
Role: PRINCIPAL_INVESTIGATOR
Clinical Pharmacology Unit, Liege, Belgium
Peter Öhman, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca, Wilmington, USA
Deborah Price, MSc
Role: STUDY_CHAIR
AstraZeneca, Wilmington, USA
Locations
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Research Site
Buenos Aires, Buenos Aires, Argentina
Research Site
Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
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Caba, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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Aalst, Belgium, Belgium
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Bonheiden, Belgium, Belgium
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Genk, Belgium, Belgium
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Gozée, Belgium, Belgium
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Hasselt, Belgium, Belgium
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Liège, Belgium, Belgium
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Saint-Médard, Belgium, Belgium
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Sint-Gillis-Waas, Belgium, Belgium
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Tessenderlo, Belgium, Belgium
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Thuillies, Belgium, Belgium
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Bruges, , Belgium
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Aalborg, , Denmark
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Aarhus, , Denmark
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Christiansfeld, , Denmark
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Farsø, , Denmark
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Gentofte Municipality, , Denmark
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Hobro, , Denmark
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Kolding, , Denmark
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Rødovre Municipality, , Denmark
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Viborg, , Denmark
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Angers, , France
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Château-Gontier, , France
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Corbeil-Essonnes, , France
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La Seyne-sur-Mer, , France
Research Site
Laval, , France
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Le Lavandou, , France
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Montrevault, , France
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Saint-Cyr, , France
Research Site
Tiercé, , France
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Toulon, , France
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Witry-lès-Reims, , France
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Bergamo, BG, Italy
Research Site
Foggia, FG, Italy
Research Site
Chiavari, GE, Italy
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Genova, GE, Italy
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Rozzano, MI, Italy
Research Site
Olbia, OT, Italy
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Padua, PD, Italy
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Pordenone, PN, Italy
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Mercato San Severino, SA, Italy
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Siena, SI, Italy
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México, D.f., Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, , Mexico
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Ålesund, , Norway
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Elverum, , Norway
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Halden, , Norway
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Hamar, , Norway
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Lierskogen, , Norway
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Lillehammer, , Norway
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Oslo, , Norway
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Sandvika, , Norway
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Strømmen, , Norway
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Svelvik, , Norway
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Benoni, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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Cape Town, Western Cape, South Africa
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Bloemfontein, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Kwa Zulu Natal, , South Africa
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Pretoria, , South Africa
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Borås, , Sweden
Research Site
Degeberga, , Sweden
Research Site
Finspång, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Jönköping, , Sweden
Research Site
Ödeshög, , Sweden
Research Site
Örebro, , Sweden
Research Site
Piteå, , Sweden
Research Site
Rättvik, , Sweden
Research Site
Skanör, , Sweden
Research Site
Timrå, , Sweden
Research Site
Trollhättan, , Sweden
Research Site
Uddevalla, , Sweden
Research Site
Umeå, , Sweden
Countries
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Other Identifiers
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EudraCT number 2007-006095-11
Identifier Type: -
Identifier Source: secondary_id
D1680C00002
Identifier Type: -
Identifier Source: org_study_id
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