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Clinical Trial Details

Trial ID: L5123
Source ID: NCT01117584
Associated Drug: Ipragliflozin
Title: A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus
Acronym: BALANCE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ipragliflozin|DRUG: Placebo|DRUG: Metformin
Outcome Measures: Primary: Change from baseline in HbA1c at Week 12, Baseline, 12 weeks | Secondary: Change from baseline in fasting plasma glucose (FPG) at Week 12, Baseline, 12 weeks|Achievement of target goal (HbA1c <7.0%) at Week 12, 12 weeks|Achievement of target goal (HbA1c <6.5%) at Week 12, 12 weeks
Sponsor/Collaborators: Sponsor: Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 343
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-04-06
Completion Date: 2011-04-01
Results First Posted:
Last Update Posted: 2024-11-06
Locations: Los Angeles, California, 90036, United States|Coral Gables, Florida, 33134, United States|Hialeah, Florida, 33012, United States|Kissimmee, Florida, 34741, United States|Las Vegas, Nevada, 89106, United States|Baja, 6500, Hungary|Balatonfured, 8230, Hungary|Budapest, 1036, Hungary|Budapest, 1076, Hungary|Gyongyos, 3200, Hungary|Mako, 6900, Hungary|Nyiregyhaza, 4400, Hungary|Zalaegerszeg, 8900, Hungary|Ancona, 60100, Italy|Milan, 20132, Italy|Sienna, 53100, Italy|Chrzanow, 32-500, Poland|Katowice, 40-752, Poland|Krakow, 30-015, Poland|Krakow, 30-550, Poland|Kutno, 99-330, Poland|Lodz, 90-302, Poland|Lublin, 20-044, Poland|Warszawa, 03-003, Poland|Wroclaw, 50-127, Poland|Wroclaw, 50-349, Poland|Brasov, 500269, Romania|Brasov, 500365, Romania|Bucharest, 010492, Romania|Bucharest, 011234, Romania|Bucharest, 020475, Romania|Bucuresti, 020275, Romania|Bucuresti, 020475, Romania|Bucuresti, 20045, Romania|Constanta, 900675, Romania|Craiova, 200642, Romania|Lasi, 700547, Romania|Ploiesti, 100018, Romania|Ploiesti, 100163, Romania|Sibiu, 550245, Romania|Sibiu, 550371, Romania|Birmingham, B15 2SQ, United Kingdom|Cambridgeshire, CB8 9PW, United Kingdom|Manchester, M15 6SX, United Kingdom|Reading, RG2 0TG, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01117584

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D089 Metformin small molecule DB00331 Details