| Trial ID: | L4472 |
| Source ID: | NCT01355718
|
| Associated Drug: |
Repaglinide
|
| Title: |
Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: repaglinide
|
| Outcome Measures: |
Primary: Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes, weeks 0-26 | Secondary: Incidence of Adverse Drug Reactions (ADRs), week 13 and 26|Incidence of Adverse Events (AEs), week 13 and 26|Incidence of Serious Adverse Event (SAEs), week 13 and 26|Change in HbA1c, after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
120
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2011-08
|
| Completion Date: |
2013-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-08-11
|
| Locations: |
Seoul, 137-920, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01355718
|
