Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
NCT ID: NCT01006590
Last Updated: 2012-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
286 participants
INTERVENTIONAL
2009-10-31
2010-12-31
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
TRIPLE
Study Groups
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1
Saxagliptin 5 mg
Saxagliptin
5 mg, oral tablet, once daily
2
Metformin 500 -1000 mg
Metformin
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
Interventions
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Saxagliptin
5 mg, oral tablet, once daily
Metformin
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
* HbA1c ≥7.0% and ≤10.0%
Exclusion Criteria
* Renal impairment as defined by a creatinine clearance \<60 mL/min/1.73 m2
* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Brussels (woluwe-st-lambert), Belgium, Belgium
Research Site
Halen, Belgium, Belgium
Research Site
Lommel, Belgium, Belgium
Research Site
Oostham, Belgium, Belgium
Research Site
Sint-Gillis-Waas, Belgium, Belgium
Research Site
Zoersel, Belgium, Belgium
Research Site
Bruges, , Belgium
Research Site
Moerkerke, , Belgium
Research Site
Tielt, , Belgium
Research Site
Châtellerault, , France
Research Site
Corbeil-Essonnes, , France
Research Site
La Rochelle, , France
Research Site
La Seyne-sur-Mer, , France
Research Site
Paris, , France
Research Site
Seysses, , France
Research Site
Tiercé, , France
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
Research Site
Leipzig, , Germany
Research Site
Ludwigshafen, , Germany
Research Site
Mannheim, , Germany
Research Site
Rhaunen, , Germany
Research Site
Schmiedeberg, , Germany
Research Site
Wahlstedt, , Germany
Research Site
Bergamo, BG, Italy
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Forlì, FC, Italy
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Milan, MI, Italy
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Padua, PD, Italy
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Pordenone, PN, Italy
Research Site
Siena, SI, Italy
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Roma, , Italy
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Seville, Andalusia, Spain
Research Site
Barcelona, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
Research Site
San Sebastián de los Reyes, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
Alicante, Valencia, Spain
Research Site
Ankara, Turkey, Turkey (Türkiye)
Research Site
Bursa, Turkey, Turkey (Türkiye)
Research Site
Kırıkkale, Turkey, Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Reading, Berks, United Kingdom
Research Site
Atherstone, Warwickshire, United Kingdom
Research Site
Royal Leamington Spa, Warwks, United Kingdom
Research Site
Warminster, Wiltshire, United Kingdom
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Westbury, Wiltshire, United Kingdom
Research Site
Ashford, , United Kingdom
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Bath, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Peterborough, , United Kingdom
Countries
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References
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Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.
Other Identifiers
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D1680L00003
Identifier Type: -
Identifier Source: org_study_id
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