Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen

Novo Nordisk A/S1 site in 1 country74 target enrollmentJanuary 2009

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin detemir

Drugsinsulin detemir

Overview

Phase: Not Applicable
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 74
Locations: 1
Primary Endpoint: Change in HbA1c from baseline
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2009

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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