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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. |
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Register:
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EUCTR |
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Last refreshed on:
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18 April 2012 |
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Main ID: |
EUCTR2004-001258-94-IT |
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Date of registration:
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12/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin Exubera on Glycemic Control in Patients with Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents.
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Scientific title:
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A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin Exubera on Glycemic Control in Patients with Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents. |
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Date of first enrolment:
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19/04/2005 |
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Target sample size:
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1100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001258-94 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Standard therapy
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Phase:
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Countries of recruitment
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Germany
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Italy
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Spain
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United Kingdom
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Contacts
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Affiliation:
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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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Type 2 Diabetes mellitus
MedDRA version: 6.1
Level: PT
Classification code 10012613
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Intervention(s)
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Product Name: EXUBERA
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin human
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Secondary ID(s)
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2004-001258-94-DE
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A2171018
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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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