Clinical Trial Details
| Trial ID: | L7241 |
| Source ID: | NCT01392677 |
| Associated Drug: | Dapagliflozin |
| Title: | Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01392677/results |
| Conditions: | Type 2 Diabetes Mellitus|High HbA1c Level|Inadequate Glycaemic Control |
| Interventions: | DRUG: dapagliflozin|DRUG: placebo |
| Outcome Measures: | Primary: Adjusted Mean Change From Baseline in HbA1c Levels, To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea., Baseline to week 24 | Secondary: Adjusted Mean Change From Baseline in FPG, To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo, Baseline to week 24|Adjusted Mean Change From Baseline in Total Body Weight, To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo, Baseline to week 24|Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF), To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, at week 24 (LOCF) between dapagliflozin and placebo, Baseline to week 24|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure, To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo, Baseline to week 8 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 311 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-10 |
| Completion Date: | 2013-08 |
| Results First Posted: | 2013-12-27 |
| Last Update Posted: | 2014-03-12 |
| Locations: | Research Site, Edmonton, Alberta, Canada|Research Site, Winnipeg, Manitoba, Canada|Research Site, St. John's, Newfoundland and Labrador, Canada|Research Site, Halifax, Nova Scotia, Canada|Research Site, Sydney Mines, Nova Scotia, Canada|Research Site, Brampton, Ontario, Canada|Research Site, Etobicoke, Ontario, Canada|Research Site, Markham, Ontario, Canada|Research Site, Smiths Falls, Ontario, Canada|Research Site, Kensington, Prince Edward Island, Canada|Research Site, Laval, Quebec, Canada|Research Site, Quebec, Canada|Research Site, Beroun, Czech Republic|Research Site, Ceske Budejovice, Czech Republic|Research Site, Jilove U Prahy, Czech Republic|Research Site, Praha 5, Czech Republic|Research Site, Praha 6, Czech Republic|Research Site, Praha, Czech Republic|Research Site, Semily, Czech Republic|Research Site, Vyskov, Czech Republic|Research Site, Asslar, Germany|Research Site, Aßlar, Germany|Research Site, Berlin, Germany|Research Site, Dresden, Germany|Research Site, Falkensee, Germany|Research Site, Neuwied, Germany|Research Site, Pirna, Germany|Research Site, Kielce, Poland|Research Site, Lodz, Poland|Research Site, Lublin, Poland|Research Site, Poznan, Poland|Research Site, Poznań, Poland|Research Site, Warszawa, Poland|Research Site, Zgierz, Poland|Research Site, Łódź, Poland|Research Site, Banska Bystrica, Slovakia|Research Site, Kosice, Slovakia|Research Site, Povazska Bystrica, Slovakia|Research Site, Rimavska Sobota, Slovakia|Research Site, Oviedo, Asturias, Spain|Research Site, Sta Coloma de Gramanet (bcn), Catalu?a, Spain|Research Site, Barcelona, Cataluna, Spain|Research Site, A Coruna, Galicia, Spain|Research Site, A Coruña, Spain|Research Site, Barcelona, Spain|Research Site, Oviedo, Spain|Research Site, Sta Coloma de Gramenet (BCN), Spain |
| URL: | https://clinicaltrials.gov/show/NCT01392677 |
