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Clinical Trial Details

Trial ID: L6314
Source ID: NCT00660907
Associated Drug: Dapagliflozin
Title: Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00660907/results
Conditions: Type 2 Diabetes
Interventions: DRUG: dapagliflozin|DRUG: glipizide|DRUG: metformin hydrochloride
Outcome Measures: Primary: Adjusted Mean Change in HbA1c Levels, To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone., Baseline to Week 52 | Secondary: Adjusted Mean Change in Body Weight, To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment., Baseline to Week 52|Proportion of Participants With at Least One Episode of Hypoglycemia, To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value., Baseline to Week 52|Proportion of Participants With Body Weight Reduction of at Least 5%, To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value., Baseline to Week 52
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1217
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-03
Completion Date: 2013-01
Results First Posted: 2013-08-23
Last Update Posted: 2015-03-30
Locations: Research Site, Buenos Aires, Argentina|Research Site, Caba, Argentina|Research Site, Capital Federal, Argentina|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Corrientes, Argentina|Research Site, Córdoba, Argentina|Research Site, La Plata, Argentina|Research Site, Rosario, Argentina|Research Site, Santa Fe, Argentina|Research Site, L'aigle, France|Research Site, Murs Erigne, France|Research Site, Nantes Cedex 1, France|Research Site, Nantes, France|Research Site, Paris, France|Research Site, Tours, France|Research Site, Vannes, France|Research Site, Bad Lauterberg, Germany|Research Site, Berlin, Germany|Research Site, Dresden, Germany|Research Site, Essen, Germany|Research Site, Frankfurt, Germany|Research Site, Hamburg, Germany|Research Site, Heilbronn, Germany|Research Site, Ludwigshafen, Germany|Research Site, Mainz, Germany|Research Site, Pirna, Germany|Research Site, Schmiedeberg, Germany|Research Site, Wangen, Germany|Research Site, Perugia, Italy|Research Site, Pisa, Italy|Research Site, Roma, Italy|Research Site, Acapulco, Mexico|Research Site, Guadalajara, Mexico|Research Site, México, Mexico|Research Site, Veracruz, Mexico|Research Site, Den Haag, Netherlands|Research Site, Deurne, Netherlands|Research Site, Gorinchem, Netherlands|Research Site, Groningen, Netherlands|Research Site, Lichtenvoorde (gld), Netherlands|Research Site, Losser, Netherlands|Research Site, Poortvliet, Netherlands|Research Site, Rotterdam, Netherlands|Research Site, Wildervank, Netherlands|Research Site, Zutphen, Netherlands|Research Site, Cape Town, South Africa|Research Site, Durban, South Africa|Research Site, Johannesburg, South Africa|Research Site, Parow, South Africa|Research Site, Pretoria, South Africa|Research Site, Umkomaas, South Africa|Research Site, Witbank, South Africa|Research Site, Alicante, Spain|Research Site, Alzira (Valencia), Spain|Research Site, Barcelona, Spain|Research Site, Cornellá de Llobregat (BCN), Spain|Research Site, Madrid, Spain|Research Site, Sevilla, Spain|Research Site, Göteborg, Sweden|Research Site, Järfälla, Sweden|Research Site, Lund, Sweden|Research Site, Malmö, Sweden|Research Site, Skene, Sweden|Research Site, Stockholm, Sweden|Research Site, Södertälje, Sweden|Research Site, Umeå, Sweden|Research Site, Addlestone, United Kingdom|Research Site, Aylesbury, United Kingdom|Research Site, Bath, United Kingdom|Research Site, Bolton, United Kingdom|Research Site, Bury St Edmonds, United Kingdom|Research Site, Cookstown, United Kingdom|Research Site, Coventry, United Kingdom|Research Site, Ecclesfield, United Kingdom|Research Site, Edinburgh, United Kingdom|Research Site, Mortimer Reading, United Kingdom|Research Site, Trowbridge, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00660907

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D184 Simvastatin small molecule DB00641 Details
D317 Glipizide small molecule DB01067 Details