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Clinical Trial Details

Trial ID: L7106
Source ID: NCT02685345
Associated Drug: Ds-8500a 25 Mg
Title: A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DS-8500a 25 mg|DRUG: DS-8500a 75 mg|DRUG: placebo
Outcome Measures: Primary: change in 24 hour weighted mean glucose, baseline (Day -1) to Day 28 | Secondary: change in fasting plasma glucose, baseline (Day -1) to Day 28|change in plasma glucose, Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal, baseline (Day -1) and Day 28|change in glycoalbumin, baseline (Day -1) and Day 28|change in serum insulin, Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal, baseline (Day -1) and Day 28|change in proinsulin, baseline (Day -1) and Day 28|change in C-peptide, Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast, baseline (Day -1) and Day 28|change in PYY (pancreatic peptide YY3-36), Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast, baseline (Day -1) and Day 28|change in total GLP-1 (Glucagon-like peptide-1), baseline (Day -1) and Day 28|change in active GLP-1 (Glucagon-like peptide-1), Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast, baseline (Day -1) and Day 28|change in total GIP (Gastric inhibitory polypeptide), Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast, baseline (Day -1) and Day 28|change in total glucagon, Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast, baseline (Day -1) and Day 28|change in total total cholesterol, baseline (Day -1) to after dosing on Day 28|change in total HDL (high density lipoprotein) cholesterol, baseline (Day -1) to after dosing on Day 28|change in total LDL (low density lipoprotein) cholesterol, baseline (Day -1) to after dosing on Day 28|change in total triglyceride, baseline (Day -1) to after dosing on Day 28|number and severity of adverse events, baseline (Day -1) to after dosing on Day 28|change in derived plasma glucose AUC, change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h, baseline (Day -1) to after dosing on Day 28|change in derived serum insulin AUC, change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h, baseline (Day -1) to after dosing on Day 28|change in derived C-peptide AUC, change in pharmacodynamic parameters derived from C-peptide; AUC0-4h, baseline (Day -1) to after dosing on Day 28|change in derived PYY AUC, change in pharmacodynamic parameters derived from PYY; AUC0-4h, baseline (Day -1) to after dosing on Day 28|change in derived total GLP-1 AUC, change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h, baseline (Day -1) to after dosing on Day 28|change in derived active GLP-1 AUC, change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h, baseline (Day -1) to after dosing on Day 28|change in derived total GIP AUC, change in pharmacodynamic parameters derived from total GIP; AUC0-4h, baseline (Day -1) to after dosing on Day 28|change in derived glucagon AUC, change in pharmacodynamic parameters derived from glucagon; AUC0-4h, baseline (Day -1) to after dosing on Day 28
Sponsor/Collaborators: Sponsor: Daiichi Sankyo Co., Ltd. | Collaborators: Mediscience Planning, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 85
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-01
Completion Date: 2016-10
Results First Posted:
Last Update Posted: 2019-02-12
Locations: Yodogawaku, Osaka, 565-0853, Japan
URL: https://clinicaltrials.gov/show/NCT02685345