| Trial ID: | L5959 |
| Source ID: | NCT01042106
|
| Associated Drug: |
Dsp-8658
|
| Title: |
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: DSP-8658|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety assessments include physical examination, laboratory variables and ECG., 20 days | Secondary: Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study., 20 days|Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study., 18 days
|
| Sponsor/Collaborators: |
Sponsor: Sumitomo Pharma America, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-11
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2013-09-16
|
| Locations: |
Cetero Research, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01042106
|
