| Trial ID: | L3679 |
| Source ID: | NCT00698269
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir|DRUG: biphasic insulin aspart 30|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: Incidence of major hypoglycaemic events reported, during 24 weeks of treatment|Change in HbA1c, during 24 weeks of treatment | Secondary: Percentage of subjects achieving HbA1c below 7.0%, at 12 & 24 weeks|Change in FPG, at 12 & 24 weeks|Change in PPG, at 12 & 24 weeks|Body weight, at 12 & 24 weeks|Change in number of hypoglycaemic events in the last 4 weeks before routine visits, at 12 & 24 weeks|Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits, at 12 & 24 weeks|Number of adverse drug reactions (ADR), at 12 & 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
5926
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-02
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Riyadh, 3542, Saudi Arabia
|
| URL: |
https://clinicaltrials.gov/show/NCT00698269
|
