Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

Novo Nordisk A/S480 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

480

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

insulin aspartDRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

human soluble insulinDRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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®)

Locations (1)

Novo Nordisk Investigational Site

Bratislava, Slovakia

Outcomes

Primary Outcomes

Change in HbA1c (glycosylated haemoglobin)

Secondary Outcomes

Change in 7-point blood glucose variability

Change in body weight

Insulin dose

Number of injections

Number of hypoglycaemic episodes

Number of adverse events

Data from ClinicalTrials.gov

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