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Clinical Trial Details

Trial ID: L4737
Source ID: NCT01006590
Associated Drug: Saxagliptin
Title: Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
Acronym: PROMPT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01006590/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin|DRUG: Metformin
Outcome Measures: Primary: Absolute Change From Baseline in HbA1c at Week 24, Baseline and 24 weeks | Secondary: Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%, Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent, 24 Weeks|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%, Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent, 24 Weeks|Change From Baseline to Week 24 in Fasting Plasma Glucose, Baseline and 24 weeks|Change From Baseline to Week 24 in Fasting Insulin, Baseline and 24 weeks|Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta, Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 286
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-10
Completion Date: 2010-12
Results First Posted: 2012-01-05
Last Update Posted: 2012-01-19
Locations: Research Site, Brugge, Belgium|Research Site, Brussels (woluwe-st-lambert), Belgium|Research Site, Halen, Belgium|Research Site, Lommel, Belgium|Research Site, Moerkerke, Belgium|Research Site, Oostham, Belgium|Research Site, Sint-gillis-waas, Belgium|Research Site, Tielt, Belgium|Research Site, Zoersel, Belgium|Research Site, Chatellerault, 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, Tierce, France|Research Site, Berlin, Germany|Research Site, Freiburg, 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|Research Site, Forli, FC, Italy|Research Site, Milano, MI, Italy|Research Site, Padova, PD, Italy|Research Site, Pordenone, PN, Italy|Research Site, Siena, SI, Italy|Research Site, Roma, Italy|Research Site, Sevilla, Andalucia, Spain|Research Site, Oviedo, Asturias, Spain|Research Site, Barcelona, Cataluna, Spain|Research Site, Madrid, Comunidad de Madrid, Spain|Research Site, San Sebastian de Los Reyes, Comunidad de Madrid, Spain|Research Site, Alicante, Comunidad Valenciana, Spain|Research Site, A Coruna, Galicia, Spain|Research Site, Ankara, Turkey|Research Site, Bursa, Turkey|Research Site, Kirikkale, Turkey|Research Site, Reading, Berks, United Kingdom|Research Site, Atherstone, Warwickshire, United Kingdom|Research Site, Leamington Spa, Warwks, United Kingdom|Research Site, Warminster, Wiltshire, United Kingdom|Research Site, Westbury, Wiltshire, United Kingdom|Research Site, Ashford, United Kingdom|Research Site, Bath, United Kingdom|Research Site, Coventry, United Kingdom|Research Site, Peterborough, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01006590

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details
D089 Metformin small molecule DB00331 Details