Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice. Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate
Exclusion criteria
* Current treatment with insulin * Known or suspected allergy to Levemir® or excipients * Children below the age of 6 years * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia | during 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of major and minor hypoglycaemic events | in the 4 weeks preceding trial start, and at the 12 and 24 week visits |
| HbA1c and its change from trial start | at the 12 and 24 week visits |
| Incidence of all adverse drug reactions (ADRs) | during 24 weeks of treatment |
| FBG variability (measured as standard deviation of FBG) and its change from trial start | at the 12 and 24 weeks visits |
| Body weight and its change from trial start | at the 12 and 24 week visits |
| Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start | at the 12 and 24 week visits |
Countries
Canada, China, Germany, Israel, Italy, Poland, Portugal, Spain, Turkey (Türkiye)
Outcome results
None listed