Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®

NCT ID: NCT00658099

Last Updated: 2017-01-31

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

699 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-06-30

Brief Summary

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This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or 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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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin detemir

Intervention Type DRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

B

insulin NPH

Intervention Type DRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Interventions

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insulin detemir

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Intervention Type DRUG

insulin NPH

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* HbA1c greater than 7.0% and/or hypoglycaemia
* variable FBG and/or weight increase
* the selection of the subjects will be at the discretion of the participating physician

Exclusion Criteria

* non-type 2 diabetes
* current treatment with Levemir® or Insulatard®
* hypersensitivity to Levemir® or Insulatard® or to any of the excipients
* women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
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

Bucharest, , Romania

Site Status

Countries

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Romania

References

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Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1976

Identifier Type: -

Identifier Source: org_study_id

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