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Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes | Clinical Trials | Clareo Health

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Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

NCT00825643•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice. Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria

•Current treatment with insulin
•Known or suspected allergy to Levemir® or excipients
•Children below the age of 6 years
•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

Locations (9)

Novo Nordisk Investigational Site

Mississauga, Canada

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Mainz, Germany

Novo Nordisk Investigational Site

Kfar Saba, Israel

Novo Nordisk Investigational Site

Rome, Italy

Novo Nordisk Investigational Site

Warsaw, Poland

Novo Nordisk Investigational Site

Paço de Arcos, Portugal

Novo Nordisk Investigational Site

Madrid, Spain

Novo Nordisk Investigational Site

Istanbul, Turkey (Türkiye)

Key Dates

Start Date

April 1, 2008

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

February 13, 2017

Enrollment

18,481

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin detemir

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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