| Trial ID: | L3367 |
| Source ID: | NCT01588639
|
| Associated Drug: |
Insulin (Scilin N, Bay81-9924)
|
| Title: |
To Evaluate Clinical Outcome and Injection Compliance of Scilin
|
| Acronym: |
SEAS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin (Scilin N, BAY81-9924)|DRUG: Insulin (Scilin R _BAY81-9924|DRUG: Insulin(Scilin M30_BAY81-9924)
|
| Outcome Measures: |
Primary: Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events, up to 12 week | Secondary: Occurrence rate of hypoglycemic events, up to 12 weeks|Change in HbA1c, Baseline and week 12|Change in FPG (Fasting Plasma Glucose), Baseline and week 12|Change in PPG (Postprandial Glucose), Baseline and week 12|The ratio of compliance injection (following physician's advice), up to 12 weeks|Number and ratio of missed injections, up to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
2683
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2012-08
|
| Completion Date: |
2014-01
|
| Results First Posted: |
|
| Last Update Posted: |
2015-01-13
|
| Locations: |
Many Locations, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01588639
|
