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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806897

Acronym

LITHULEV1

Enrollment

Registered

2008-12-11

Start date

2009-01-31

Completion date

2009-12-31

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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

Interventions

DRUGinsulin detemir

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	at 24 weeks

Secondary

Measure	Time frame
Change in body weight	at 12 weeks/24weeks

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026