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Clinical Trial Details

Trial ID: L4643
Source ID: NCT02222350
Associated Drug: 10mg Ds-8500a Tablet
Title: Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 10mg DS-8500a tablet|DRUG: 75mg DS-8500a tablet|DRUG: placebo
Outcome Measures: Primary: change in 24-hour weighted mean blood glucose, Day -1 (baseline) to Day 28 | Secondary: change in 24 hour weighted mean blood glucose, Day -1 (baseline) to Day 14|change in blood fasting plasma glucose level, Day -1 (baseline) to Days 7, 14, 21, 28|change in blood plasma glucose level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood insulin level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood C-peptide level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood active GLP-1 level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood PYY level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood HbA1c level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|change in blood glycoalbumin level, Change in the parameter at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28|Number of subjects experiencing adverse events as a measure of safety, Number of subjects experiencing adverse events, Day -1 (baseline) to Day 28|pharmacokinetic profile of DS-8500a, Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2, Day -1 (baseline) to Day 28|change in postprandial plasma glucose level, Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1, Day -1 (baseline) to Days 14 and 28
Sponsor/Collaborators: Sponsor: Daiichi Sankyo Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-07
Completion Date: 2015-01
Results First Posted:
Last Update Posted: 2019-02-12
Locations: Heishinkai Medical Group Incorporated OCROM Clinic, Kasuga, Osaka, 565-0853, Japan
URL: https://clinicaltrials.gov/show/NCT02222350