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Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00793273
Enrollment
1074
Registered
2008-11-19
Start date
2008-11-30
Completion date
2011-01-31
Last updated
2014-08-15

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 observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

Interventions

DRUGinsulin detemir

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Patients with type 2 diabetes mellitus * Insulin-naive or currently treated with another basal insulin * Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

Exclusion criteria

* Type 1 diabetes mellitus * Patients treated with short acting or with premix insulin * Women who are pregnant, breast feeding or have the intention to become pregnant * Known or suspected allergy to the study product or related product * Any

Design outcomes

Primary

MeasureTime frame
Change in HbA1c of treatmentafter 12 to 16 weeks
Change in FPG (fasting plasma glucose) of treatmentafter 12 to 16 weeks

Secondary

MeasureTime frame
Occurrence of adverse eventsafter 12 to 16 weeks
Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiationafter 12 to 16 weeks

Countries

Switzerland

Outcome results

None listed

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