Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany

NCT ID: NCT00665808

Last Updated: 2016-10-28

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

8125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.

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

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

B

isophane human insulin

Intervention Type DRUG

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Interventions

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insulin detemir

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Intervention Type DRUG

isophane human insulin

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Intervention Type DRUG

Other Intervention Names

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Levemir®

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from patient before first documentation of treatment in the observational study.
* Type 2 diabetes mellitus
* Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
* No contraindication for use of Protaphane® or Levemir®

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

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

Mainz, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1951

Identifier Type: -

Identifier Source: org_study_id