Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®

Completed

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

• Registration Number: NCT00806897
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Type 2 diabetic subjects on intensive insulin treatment (IIT)
• Eligibility for once daily insulin detemir administration
• Informed consent obtained before any observation-related activities

Exclusion Criteria

• Known or suspected allergy to insulin detemir
• Subjects previously enrolled in the observation
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in body weight	at 12 weeks/24weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇱🇹 Vilnius, Lithuania