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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2004-001461-18-IT |
Date of registration:
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04/03/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes
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Scientific title:
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A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes |
Date of first enrolment:
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06/12/2004 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001461-18 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Combined therapy in diabetes mellitus MedDRA version: 6.1
Level: PT
Classification code 10012601
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Intervention(s)
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Trade Name: Levemir Product Name: NA Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulins and analogues, long-acting Current Sponsor code: NN304 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 10-
Trade Name: PROTAPHANE HM PEN.*5CAR 3 ML Product Name: NA Product Code: NA Pharmaceutical Form: Suspension for injection INN or Proposed INN: Insulin (human) Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Primary end point(s):
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Secondary Objective:
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Main Objective:
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Secondary ID(s)
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NN304-1632
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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