| Trial ID: | L3731 |
| Source ID: | NCT00264901
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes
|
| Acronym: |
PREDICTIVE™
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Comparison of the change from baseline to end of treatment, after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group | Secondary: Spontaneously reported adverse events during the trial|Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)|FPG during the trial (central laboratory) at Visit 2 and Visit 3|Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3|Insulin detemir doses at Visit 2 and Visit 3|Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
5652
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-10
|
| Completion Date: |
2006-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-31
|
| Locations: |
Novo Nordisk Investigational Site, Plainsboro, New Jersey, 08536, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00264901
|
