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Observational Study to Evaluate the Safety of Levemir® in Diabetes

NCT00659295 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51170

Last updated 2017-03-10

Study results available
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Summary

This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin detemir

Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Ireland
  • Israel
  • Italy
  • South Korea
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00659295 on ClinicalTrials.gov