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Efficacy and Safety of Levemir® Used as Basal Insulin

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ClinicalTrials.gov Identifier: NCT01548248
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin aspart

Study Type : Observational
Actual Enrollment : 631 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Levemir® users 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.



Primary Outcome Measures :
  1. Change in HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Change in weight
  2. Change in fasting plasma glucose (FPG)
  3. Change in 4-points glucose profiles
  4. Change in lipid profile
  5. Number of hypoglycaemic events
  6. Number of adverse events


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes treated with insulin NPH

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548248


Locations
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Zuzana N et al; Effect of Basal Insulin Detemir on Weight and Hypoglycemia in T1DM and T2DM; 2025-PO; 69th Scientific Sessions (2009); American Diabetes Association

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01548248     History of Changes
Other Study ID Numbers: NN304-1928
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs