| Trial ID: | L7181 |
| Source ID: | NCT00454233
|
| Associated Drug: |
Ym543
|
| Title: |
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: YM543|DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination), 3 Months | Secondary: Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel), 3 Months
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
97
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-02
|
| Completion Date: |
2008-06
|
| Results First Posted: |
|
| Last Update Posted: |
2008-10-16
|
| Locations: |
Ekaterinburg, Russian Federation|4 Sites, Moscow, Russian Federation|N. Novgorod, Russian Federation|Petrozavodsk, Russian Federation|Samara, Russian Federation|10 Sites, St. Petersburg, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT00454233
|
