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Clinical Trial Details

Trial ID: L2711
Source ID: NCT02628392
Associated Drug: Ds-8500a
Title: A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: DS-8500a|DRUG: Sitagliptin|DRUG: placebo
Outcome Measures: Primary: change in HbA1c, HbA1c = glycated hemoglobin, baseline (Day -1) to Week 12 | Secondary: change in HbA1c, baseline (Day -1) to Week 4|change in HbA1c, baseline (Day -1) to Week 8|proportion of subjects with HbA1c <7.0, proportion of subjects who achieve HbA1c \<7.0, baseline (Day -1) to Week 12|change in plasma glucose, baseline (Day -1) to Week 4|change in plasma glucose, baseline (Day -1) to Week 12|change in AUC derived from plasma glucose, change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax), baseline (Day -1) to Week 4|change in AUC derived from plasma glucose, pharmacodynamics profile consists of AUC, Cmax, Tmax, baseline (Day -1) to Week 12|change in serum insulin, baseline (Day -1) to Week 4|change in AUC 0-3h serum insulin, baseline (Day -1) to Week 4|change in serum insulin, baseline (Day -1) to Week 12|change in AUC 0-3h serum insulin, baseline (Day -1) to Week 12|change in proinsulin, baseline (Day -1) to Week 4|change in AUC 0-3h proinsulin, baseline (Day -1) to Week 4|change in proinsulin, baseline (Day -1) to Week 12|change in AUC 0-3h proinsulin, baseline (Day -1) to Week 12|change in C-peptide, baseline (Day -1) to Week 4|change in AUC 0-3h C-peptide, baseline (Day -1) to Week 4|change in C-peptide, baseline (Day -1) to Week 12|change in AUC 0-3h C-peptide, baseline (Day -1) to Week 12|change in PYY, PYY = peptide YY, baseline (Day -1) to Week 4|change in AUC 0-3h PYY, baseline (Day -1) to Week 4|change in PYY, baseline (Day -1) to Week 12|change in AUC 0-3h PYY, baseline (Day -1) to Week 12|change in total GLP-1, GLP-1 = Glucagon-Like Peptide-1, baseline (Day -1) to Week 4|change in total AUC 0-3h GLP-1, baseline (Day -1) to Week 4|change in total GLP-1, baseline (Day -1) to Week 12|change in AUC 0-3h total GLP-1, baseline (Day -1) to Week 12|change in active GLP-1, baseline (Day -1) to Week 4|change in AUC 0-3h active GLP-1, baseline (Day -1) to Week 4|change in active GLP-1, baseline (Day -1) to Week 12|change in AUC 0-3h active GLP-1, baseline (Day -1) to Week 12|change in total GIP, GIP = Gastric Inhibitory Polypeptide, baseline (Day -1) to Week 4|change in AUC 0-3h total GIP, baseline (Day -1) to Week 4|change in total GIP, baseline (Day -1) to Week 12|change in AUC 0-3h total GIP, baseline (Day -1) to Week 12|change in glucagon, baseline (Day -1) to Week 4|change in AUC 0-3h glucagon, baseline (Day -1) to Week 4|change in glucagon, baseline (Day -1) to Week 12|change in AUC 0-3h glucagon, baseline (Day -1) to Week 12|change in 1,5 AG, 1,5 AG = 1,5 anhydrogucitol, baseline (Day -1) to Week 4|change in AUC 0-3h 1,5 AG, baseline (Day -1) to Week 4|change in 1,5 AG, baseline (Day -1) to Week 12|change in AUC 0-3h 1,5 AG, baseline (Day -1) to Week 12|change in total cholesterol, baseline (Day -1) to Week 2|change in total cholesterol, baseline (Day -1) to Week 4|change in total cholesterol, baseline (Day -1) to Week 8|change in total cholesterol, baseline (Day -1) to Week 12|change in HDL cholesterol, HDL = high density lipoprotein, baseline (Day -1) to Week 2|change in HDL cholesterol, baseline (Day -1) to Week 4|change in HDL cholesterol, baseline (Day -1) to Week 8|change in HDL cholesterol, baseline (Day -1) to Week 12|change in LDL cholesterol, LDL = low density lipoprotein, baseline (Day -1) to Week 2|change in LDL cholesterol, baseline (Day -1) to Week 4|change in LDL cholesterol, baseline (Day -1) to Week 8|change in LDL cholesterol, baseline (Day -1) to Week 12|change in triglyceride, baseline (Day -1) to Week 2|change in triglyceride, baseline (Day -1) to Week 4|change in triglyceride, baseline (Day -1) to Week 8|change in triglyceride, baseline (Day -1) to Week 12
Sponsor/Collaborators: Sponsor: Daiichi Sankyo Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 368
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-11
Completion Date: 2016-09
Results First Posted:
Last Update Posted: 2019-02-12
Locations: Heishinkai Medical Group Incorporated OCROM Clinic, Suita-shi, Osaka, Japan
URL: https://clinicaltrials.gov/show/NCT02628392