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Efficacy and Safety of Levemir® Used as Basal Insulin

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01548248
First received: March 5, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 5, 2012
March 5, 2012
January 2006
October 2006   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Change in weight [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) [ Designated as safety issue: No ]
  • Change in 4-points glucose profiles [ Designated as safety issue: No ]
  • Change in lipid profile [ Designated as safety issue: No ]
  • Number of hypoglycaemic events [ Designated as safety issue: No ]
  • Number of adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Levemir® Used as Basal Insulin
An Observational 3−Months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes

This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Any subject with type 1 or type 2 diabetes treated with human insulin NPH in whom at the discretion of the participating physicians it was decided to switch insulin treatment to the long-acting insulin analogue insulin detemir in combination with insulin aspart. The selection of the subjects was at the discretion of the participating physicians.

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
  • Drug: insulin aspart
    Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
Levemir® users
Interventions:
  • Drug: insulin detemir
  • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
631
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or type 2 diabetes treated with insulin NPH
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT01548248
NN304-1928
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: M. Suplatova Novo Nordisk Slovakia s.r.o.
Novo Nordisk A/S
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP