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

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

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Vilnius, 01112, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Other names: Levemir®, NN304

Primary outcomes

Change in HbA1c from baseline

Time frame: at 24 weeks

Secondary outcomes

Change in body weight

Time frame: at 12 weeks/24weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: LITHULEV1

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Dec 11, 2008
Registry last updated: Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed