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Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

NCT ID: NCT00715351

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-07-31

Brief Summary

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This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

B

insulin NPH

Intervention Type DRUG

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

Interventions

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insulin detemir

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

Intervention Type DRUG

insulin NPH

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria

* Type 1 diabetes
* Previous use of insulin
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Ljubljana, , Slovenia

Site Status

Countries

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Netherlands Slovenia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1896

Identifier Type: -

Identifier Source: org_study_id