ID

20776

Description

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00308737

Link

https://clinicaltrials.gov/show/NCT00308737

Keywords

Versions (4)
  1. 3/16/17 3/16/17 -
  2. 3/16/17 3/16/17 -
  3. 3/16/17 3/16/17 -
  4. 3/16/17 3/16/17 -
Uploaded on

March 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes, Type 1 NCT00308737

English

Eligibility Diabetes, Type 1 NCT00308737

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for all subjects:
Description

Study Subject All

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
nonsmoking
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
body mass index <42 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fev1 greater than or equal to 70% of predicted , dlco and tlc greater than or equal to 80% of predicted at screening,
Description

FEV1 | Carbon Monoxide Diffusing Capability Test | Total Lung Capacity

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1516251
UMLS CUI [3]
C0040509
no abnormalities in screening pulmonary radiology
Description

Radiology Lung Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C0205307
for subjects with diabetes mellitus:
Description

Study Subject Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011849
type 1 or type 2 diabetes for at least 2 years
Description

Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
hba1c greater than or equal to 6.6 % and less than or equal to 12.0 %
Description

Glycosylated hemoglobin A Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
for subjects without abnormalities in glucose control:
Description

Study Subject GLUCOSE CONTROL Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0726398
UMLS CUI [1,3]
C0205307
no history of diabetes
Description

H/O: diabetes mellitus Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0455488
UMLS CUI [1,2]
C0332197
normal results from a formal glucose tolerance test
Description

Glucose tolerance test normal

Data type

boolean

Alias
UMLS CUI [1]
C0438251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
Description

Chronic Obstructive Airway Disease | Asthma | Lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0024115
significant renal, hepatic, or cardiac disease
Description

Kidney Diseases | Liver diseases | Heart Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018799
women who are pregnant, lactating, or planning on becoming pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
subjects who have participated in studies of other investigational drugs within the previous 3 months
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
evidence of severe complications of diabetes
Description

Complications of Diabetes Mellitus Severe Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332120
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Similar models

Eligibility Diabetes, Type 1 NCT00308737

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All
Item
for all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Non-smoker
Item
nonsmoking
boolean
C0337672 (UMLS CUI [1])
Body mass index
Item
body mass index <42 kg/m2
boolean
C1305855 (UMLS CUI [1])
FEV1 | Carbon Monoxide Diffusing Capability Test | Total Lung Capacity
Item
fev1 greater than or equal to 70% of predicted , dlco and tlc greater than or equal to 80% of predicted at screening,
boolean
C0748133 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
C0040509 (UMLS CUI [3])
Radiology Lung Normal
Item
no abnormalities in screening pulmonary radiology
boolean
C0043299 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Study Subject Diabetes Mellitus
Item
for subjects with diabetes mellitus:
boolean
C0681850 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 1 or type 2 diabetes for at least 2 years
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Glycosylated hemoglobin A Percentage
Item
hba1c greater than or equal to 6.6 % and less than or equal to 12.0 %
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Study Subject GLUCOSE CONTROL Normal
Item
for subjects without abnormalities in glucose control:
boolean
C0681850 (UMLS CUI [1,1])
C0726398 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
H/O: diabetes mellitus Absent
Item
no history of diabetes
boolean
C0455488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Glucose tolerance test normal
Item
normal results from a formal glucose tolerance test
boolean
C0438251 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease | Asthma | Lung diseases
Item
history of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
Kidney Diseases | Liver diseases | Heart Diseases
Item
significant renal, hepatic, or cardiac disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, lactating, or planning on becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
subjects who have participated in studies of other investigational drugs within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Complications of Diabetes Mellitus Severe Evidence
Item
evidence of severe complications of diabetes
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
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