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Clinical Trials/NCT01542489
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

Novo Nordisk A/S1 site in 1 country480 target enrollmentStarted: October 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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