Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00472953
Last Updated: 2017-03-01
Study Results
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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TERMINATED
PHASE3
38 participants
INTERVENTIONAL
2007-05-15
2008-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
B
insulin aspart
Treat-to-target dose titration scheme, pre-prandial, injection s.c.
Interventions
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inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
insulin aspart
Treat-to-target dose titration scheme, pre-prandial, injection s.c.
Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes
* HbA1c lower or equal to 11.0 %
* Body Mass Index (BMI) lower or equal to 40.0 kg/m2
Exclusion Criteria
* Current smoking or smoking within the last 6 months
* Other pulmonary disease including asthma
* Proliferative retinopathy or maculopathy requiring acute treatment
30 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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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
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Chandigarh, Punjab, India
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Hyderabad, , India
Novo Nordisk Investigational Site
Mumbai, , India
Novo Nordisk Investigational Site
Pune, , India
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Košice, , Slovakia
Novo Nordisk Investigational Site
Ľubochňa, , Slovakia
Novo Nordisk Investigational Site
Moldava nad Bodvou, , Slovakia
Novo Nordisk Investigational Site
Žilina, , Slovakia
Novo Nordisk Investigational Site
Žilina, , Slovakia
Novo Nordisk Investigational Site
Changhua, , Taiwan
Novo Nordisk Investigational Site
Chiayi City, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Erzurum, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Gaziantep, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kocaeli, , Turkey (Türkiye)
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-004731-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1998-1617
Identifier Type: -
Identifier Source: org_study_id
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