| Trial ID: | L2162 |
| Source ID: | NCT01316094
|
| Associated Drug: |
Asp1941
|
| Title: |
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ASP1941|DRUG: placebo
|
| Outcome Measures: |
Primary: changes in Hemoglobin A1c (HbA1c), baseline and 24 weeks | Secondary: changes in fasting plasma glucose, baseline and 24 weeks|changes in fasting serum insulin level, baseline and 24 weeks|changes in eGFR (estimated glomerular filtration rate), baseline and 52 weeks|safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs, for 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
165
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01-18
|
| Completion Date: |
2012-11-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kansai, Japan|Kantou, Japan|Kyushu, Japan|Shikoku, Japan|Touhoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01316094
|
