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Clinical Trial Details

Trial ID: L6512
Source ID: NCT02004678
Associated Drug: Ds-1150b
Title: Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DS-1150b|OTHER: Placebo
Outcome Measures: Primary: area under curve (AUC), To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19|maximum plasma concentration (Cmax), To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19|terminal elimination half-life (t1/2), To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19|time to reach maximum plasma concentration (Tmax), To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19 | Secondary: measure the effects on Insulin and C-peptide Levels, To assess the effects of single oral dose of DS-1150b on insulin and C-peptide levels in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19|number of patients experiencing adverse events, To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus., 24 days, Day -5 to Day 19|measure the effects on glucagon Levels, To assess the effects of single oral dose of DS-1150b on glucagon levels in subjects with Type 2 Diabetes Mellitus., 24 days, Day -5 to Day 19|number of patients experiencing laboratory adverse events, To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus., 24 days, Day -5 to Day 19
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2013-10
Results First Posted:
Last Update Posted: 2018-12-24
Locations: Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
URL: https://clinicaltrials.gov/show/NCT02004678