DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, single-blind (subject and investigator-blinded, sponsor-unblinded), sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of multiple doses of DS-7309 in subjects with T2DM. The safety and tolerability of each new dose level will be tested in a single day administration prior to start of repeated dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Worldwide Clinical Trials
San Antonio, Texas, United States
safety and tolerability of DS-7309
number, type and severity of adverse events
Time frame: 23 days, Day -7 through Day 16
determine the pharmacokinetics of DS-7309 after repeated doses
Cmax, Tmax, area under the concentration curve (AUC)
Time frame: 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
Time frame: 23 days, Day -7 through Day 16
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
Time frame: 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)
Time frame: 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)
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 23 days, Day -7 through Day 16