Evaluation of the Use of Levemir® in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes

Completed

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

• Registration Number: NCT01542463
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4464

Inclusion Criteria

• Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IDet users	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycaemic haemoglobin)
Fasting plasma glucose (FBG)

Secondary Outcome Measures

Name	Time	Method
Body weight change
Adverse drug reactions (ADR)
Serious adverse drug reactions (SADR)
Hypoglycaemic episodes