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Efficacy and Safety of Levemir® Used as Basal Insulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 5, 2012
First Posted Date March 8, 2012
Last Update Posted Date January 31, 2017
Study Start Date January 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2012)
Change in HbA1c (glycosylated haemoglobin)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01548248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 5, 2012)
  • Change in weight
  • Change in fasting plasma glucose (FPG)
  • Change in 4-points glucose profiles
  • Change in lipid profile
  • Number of hypoglycaemic events
  • Number of adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy and Safety of Levemir® Used as Basal Insulin
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Intervention
  • 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.
Study Groups/Cohorts Levemir® users
Interventions:
  • Drug: insulin detemir
  • Drug: insulin aspart
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2012)
631
Original Actual Enrollment Same as current
Actual Study Completion Date October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes treated with insulin NPH
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01548248
Other Study ID Numbers NN304-1928
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017