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Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)

Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00657930
Acronym
LEONCET2
Enrollment
2289
Registered
2008-04-14
Start date
2008-03-31
Completion date
2009-04-30
Last updated
2016-03-03

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 Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.

Interventions

DRUGinsulin detemir

observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetic subjects on intensive insulin treatment (ICT) * 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

MeasureTime frame
Efficacy (HbA1c)24 weeks

Secondary

MeasureTime frame
Body weight24 weeks
Hypoglycaemia frequency24 weeks
FBG variability24 weeks
Insulin dose change24 weeks

Countries

Hungary

Outcome results

None listed

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