| Trial ID: | L4362 |
| Source ID: | NCT00740519
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study on Safety of Self-titration of Once Daily Levemir®
|
| Acronym: |
SOLVE™
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Incidence of serious adverse drug reactions including major hypoglycaemic events, during treatment | Secondary: Incidence of serious adverse events and all adverse events, during treatment|Incidence of hypoglycaemic events, in the 4 weeks preceding the baseline, 12 and 20 week visits|HbA1c, at the interim study visit at 12 weeks and the end of the study visit at 20 weeks|Variability and mean of the patient's self-monitored plasma glucose measurements, at approximately 12 and 20 weeks|Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes, at approximately 12 and 20 weeks|Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo, defined by the average of the last three FBGs|Body weight, at approximately 12 and 20 weeks|Frequency of insulin adjustment, at approximately 12 and 20 weeks|Total number of visits/contacts to the clinic, related to titration, at approximately 12 and 20 weeks|HCP time used on titration training, at baseline and approximately 12 and 20 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
882
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-09
|
| Completion Date: |
2011-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-03
|
| Locations: |
Novo Nordisk Investigational Site, Crawley, RH11 9RT, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00740519
|
