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
1 other identifier
observational
631
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedJanuary 31, 2017
January 1, 2017
9 months
March 5, 2012
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (glycosylated haemoglobin)
Secondary Outcomes (6)
Change in weight
Change in fasting plasma glucose (FPG)
Change in 4-points glucose profiles
Change in lipid profile
Number of hypoglycaemic events
- +1 more secondary outcomes
Study Arms (1)
Levemir® users
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- Type 1 or type 2 diabetes treated with insulin NPH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Bratislava, 811 05, Slovakia
Related Publications (1)
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
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 8, 2012
Study Start
January 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
January 31, 2017
Record last verified: 2017-01