| Trial ID: | L2935 |
| Source ID: | NCT01709929
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
|
| Acronym: |
PREDICTIVE™
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events | Secondary: Number of adverse events (all and serious)|Number of all hypoglycaemic events|Change in weight|HbA1c (glycosylated haemoglobin)|Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2287
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-10
|
| Completion Date: |
2006-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-03
|
| Locations: |
Mississauga, L4W 4XI, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01709929
|
