Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7058
Source ID: NCT01956305
Associated Drug: Ds-7309
Title: Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DS-7309|DRUG: placebo|DRUG: Metformin
Outcome Measures: Primary: safety and tolerability of DS-7309, number, type and severity of adverse events, 23 days, Day -7 through Day 16|determine the pharmacokinetics of DS-7309 after repeated doses, Cmax, Tmax, area under the concentration curve (AUC), 23 days, Day-7 through Day 16|determine glycemic response, glycemic response will be assessed by blood sampling for plasma glucose after a meal tolerance test and from 24h weighted mean glucose on Day -1 and Day 12, 23 days, Day -7 through Day 16 | Secondary: To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects, To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects, 23 days, Day -7 through Day 16|To assess the effects of repeated doses of DS-7309 on blood pressure, To assess the effects of repeated doses of DS-7309 on blood pressure (by means of 24 h ambulatory blood pressure measurements (ABPMs), 23 days, Day -7 through Day 16|To assess the effects of repeated doses of DS-7309 on lipid profile, To assess the effects of repeated doses of DS-7309 on lipid profile (total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol and triglycerides), 23 days, Day -7 through Day 16|To assess the effects of repeated doses of DS-7309 on plasma lactate levels, To assess the effects of repeated doses of DS-7309 on plasma lactate levels, 23 days; Day -7 through Day 16|To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects, To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects, 23 days, Day -7 through Day 16|To assess the effects of repeated doses of DS-7309 on glucagon levels in T2DM subjects, To assess the effects of repeated doses of DS-7309 on glucagon levels in T2DM subjects, 23 days, Day -7 through Day 16
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2014-06
Results First Posted:
Last Update Posted: 2014-11-24
Locations: Worldwide Clinical Trials, San Antonio, Texas, 78217, United States
URL: https://clinicaltrials.gov/show/NCT01956305