| Trial ID: | L5466 |
| Source ID: | NCT01077570
|
| Associated Drug: |
Repaglinide
|
| Title: |
An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients
|
| Acronym: |
SAFE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: repaglinide
|
| Outcome Measures: |
Primary: Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events, at Visit 2(8 weeks) and visit 3(16 weeks) | Secondary: Number of minor hypoglycaemic (low blood sugar) episodes, at Visit 2(8 weeks) and visit 3(16 weeks)|Number of adverse drug reactions (ADRs), at Visit 2(8 weeks) and visit 3(16 weeks)|Change in HbA1c, after 16 weeks of treatment|Change in fasting blood glucose (FBG), after 8 and 16 weeks of treatment|Change in postprandial blood glucose (PBG), after 8 and 16 weeks treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
2033
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2010-03
|
| Completion Date: |
2011-02
|
| Results First Posted: |
|
| Last Update Posted: |
2014-06-26
|
| Locations: |
Beijing, Beijing, 100004, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01077570
|
