Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos
Completed
- Conditions
- Diabetes Mellitus, Type 2DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01542489
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
- Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IDet + HI users human soluble insulin - IDet + IAsp users insulin detemir - IDet + IAsp users insulin aspart - IDet + HI users insulin detemir -
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated haemoglobin)
- Secondary Outcome Measures
Name Time Method Insulin dose Change in body weight Change in 7-point blood glucose variability Number of hypoglycaemic episodes Number of adverse events Number of injections
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇰Bratislava, Slovakia