NCT01542489CompletedNot Applicable
An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Change in HbA1c (glycosylated haemoglobin)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IDet + IAsp users
Intervention: insulin detemir (Drug)
IDet + IAsp users
Intervention: insulin aspart (Drug)
IDet + HI users
Intervention: insulin detemir (Drug)
IDet + HI users
Intervention: human soluble insulin (Drug)
Outcomes
Primary Outcomes
Change in HbA1c (glycosylated haemoglobin)
Secondary Outcomes
- Change in body weight
- Change in 7-point blood glucose variability
- Number of hypoglycaemic episodes
- Insulin dose
- Number of adverse events
- Number of injections
Investigators
Study Sites (1)
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