Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.
Interventions
DRUGinsulin detemir
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician * Patient willing to sign informed consent * Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels
Exclusion criteria
* Subjects with diagnosed type 1 diabetes mellitus * Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits) * Subjects with hypersensitivity to Levemir® or to any of the ingredients * Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | after 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5% | after 12 weeks and 24 weeks |
| Change in FPG (Fasting Plasma Glucose) | after 12 weeks and 24 weeks |
| Change in body weight | after 12 weeks and 24 weeks |
| Change in waist and hip circumference | after 12 weeks and 24 weeks |
Countries
Hungary
Outcome results
None listed