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Clinical Trial Details

Trial ID: L5696
Source ID: NCT02452632
Associated Drug: Asp1941
Title: A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ASP1941|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in HbA1c at the end of treatment, at 24 weeks | Secondary: Change from baseline in Fasting plasma glucose at the end of treatment, at 24 weeks|Change from baseline in Fasting serum insulin at the end of treatment, at 24 weeks|Change from baseline in Body weight at the end of treatment, at 24 weeks|Change from baseline in Waist circumference at the end of treatment, at 24 weeks|Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG, ECG: Electrocardiogram, up to 24 weeks|Number of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit, at 4, 8, 12, 16 and 24 weeks|Percentage of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit, at 4, 8, 12, 16 and 24 weeks
Sponsor/Collaborators: Sponsor: Astellas Pharma Korea, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 143
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-06-22
Completion Date: 2017-01-05
Results First Posted:
Last Update Posted: 2024-11-12
Locations: Site KR00002, Busan, Korea, Republic of|Site KR00003, Busan, Korea, Republic of|Site KR00007, Daegu, Korea, Republic of|Site KR00011, Daegu, Korea, Republic of|Site KR00019, Dong Gu Gwangju, Korea, Republic of|Site KR00008, Gangwon-do, Korea, Republic of|Site KR00018, Gyeonggi-do, Korea, Republic of|Site KR00022, Gyeonggi-do, Korea, Republic of|Site KR00014, Incheon, Korea, Republic of|Site KR00020, Jeollabuk-do, Korea, Republic of|Site KR00021, Kyungsangnam-do, Korea, Republic of|Site KR00001, Seoul, Korea, Republic of|Site KR00004, Seoul, Korea, Republic of|Site KR00005, Seoul, Korea, Republic of|Site KR00006, Seoul, Korea, Republic of|Site KR00009, Seoul, Korea, Republic of|Site KR00010, Seoul, Korea, Republic of|Site KR00012, Seoul, Korea, Republic of|Site KR00013, Seoul, Korea, Republic of|Site KR00016, Seoul, Korea, Republic of|Site KR00017, Seoul, Korea, Republic of|Site KR00015, Suwon, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02452632

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress