Efficacy and Safety of Levemir® Used as Basal Insulin

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir; Drug: insulin aspart

• Registration Number: NCT01548248
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

Inclusion Criteria

• Type 1 or type 2 diabetes treated with insulin NPH

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levemir® users	insulin detemir	-
Levemir® users	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
Change in lipid profile
Number of hypoglycaemic events
Number of adverse events
Change in fasting plasma glucose (FPG)
Change in 4-points glucose profiles
Change in weight

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia