Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes * Patients inadequately controlled by OAD * Patients willing to sign informed consent * Selection of study participants at the discretion of the physician * Particular attention should be paid to the drug interactions that are listed within the product label
Exclusion criteria
* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; * Subjects who were previously enrolled in this study * Subjects with a hypersensitivity to insulin detemir or to any of the excipients. * Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycaemic control as measured by HbA1c. | For the duration of the study |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% | After 12 weeks and 24 weeks |
| The effect on glycaemic control as measured by FPG | After 12 weeks and 24 weeks |
| Change in body weight | After 12 weeks and 24 weeks |
| Change in waist and hip perimeter | After 12 weeks and 24 weeks |
Countries
Slovakia
Outcome results
None listed