| Trial ID: | L7103 |
| Source ID: | NCT01302145
|
| Associated Drug: |
Asp1941
|
| Title: |
Drug to Drug Interaction Study With ASP1941 and Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ASP1941|DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring, 5 weeks | Secondary: Pharmacodynamics assessed by serum glucose change, 5 weeks|Pharmacokinetics assessed by metformin plasma concentration change, 5 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2009-02-25
|
| Completion Date: |
2009-12-09
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-28
|
| Locations: |
Balatonfured, 8230, Hungary|Budapest, 1083, Hungary|Groningen, 9470 AE, Netherlands|Warsaw, 02-097, Poland|Bratislava, 83305, Slovakia
|
| URL: |
https://clinicaltrials.gov/show/NCT01302145
|
