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NCT01548248 Clinical Trial

Efficacy and Safety of Levemir® Used as Basal Insulin

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01548248
Other study ID # NN304-1928
Secondary ID
Status Completed
Phase N/A
First received March 5, 2012
Last updated January 30, 2017
Start date January 2006
Est. completion date October 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 631
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 1 or type 2 diabetes treated with insulin NPH

Study Design

Related Conditions & MeSH terms

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.
• 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.

Locations
Country Name City State
Slovakia Novo Nordisk Investigational Site Bratislava

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

References & 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

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c (glycosylated haemoglobin)
Secondary Change in weight
Secondary Change in fasting plasma glucose (FPG)
Secondary Change in 4-points glucose profiles
Secondary Change in lipid profile
Secondary Number of hypoglycaemic events
Secondary Number of adverse events
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