| Trial ID: | L3259 |
| Source ID: | NCT01862939
|
| Associated Drug: |
Ds-7309
|
| Title: |
A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: DS-7309|DRUG: placebo
|
| Outcome Measures: |
Primary: incremental area under the curve (IAUC) blood glucose, The incremental area under the curve (IAUC) of the PD biomarker blood glucose following an oral glucose tolerance test (OGTT) in subjects with type 2 diabetes mellitus (T2DM)., 5 hours | Secondary: determine blood concentrations of DS-7309, The plasma pharmacokinetic (PK) parameters of A203-5319 (the free form of DS-7309) and relevant metabolite of DS-7309 in healthy subjects and subjects with T2DM., 48 hours
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
52
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-04
|
| Completion Date: |
2011-09
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-27
|
| Locations: |
Celerion, Tempe, Arizona, 85283, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01862939
|
