ID

29142

Beschreibung

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake; ODM derived from: https://clinicaltrials.gov/show/NCT00747006

Link

https://clinicaltrials.gov/show/NCT00747006

Stichworte

Versionen (1)
  1. 28.02.18 28.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Februar 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00747006

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnoses of type 1 or type 2 diabetes mellitus
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
fasting plasma glucose (fpg) 80, 140 mg/dl and glycated hemoglobin (a1c) > 6.5% and < or = 10.0%.
Beschreibung

Plasma fasting glucose measurement | Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0202054
body mass index (bmi) of < or = 40 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dl
Beschreibung

Non-smoker | Former smoker | Urine cotinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0337671
UMLS CUI [3]
C1278256
forced expiratory volume in 1 second (fev1) = 70% third national health and nutrition examination survey (nhanes iii) predicted; pre-bronchodilator fev1 as a percentage of forced vital capacity (fev1/forced vital capacity(fvc)) = 70%
Beschreibung

FEV1 | FEV1 pre bronchodilator Percentage Forced Vital Capacity | FEV1/FVC

Datentyp

boolean

Alias
UMLS CUI [1]
C0849974
UMLS CUI [2,1]
C0849974
UMLS CUI [2,2]
C2599602
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C3714541
UMLS CUI [3]
C3815113
for subjects with type 2 diabetes mellitus: currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Basal insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0650607
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (pft) and/or radiologic findings
Beschreibung

Chronic Obstructive Airway Disease | Asthma | Lung disease Pulmonary function tests | Lung disease Radiologic finding

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0024119
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C1290916
elevated liver function test (alanine aminotransferase [alt] or aspartate aminotransferase [ast] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
Beschreibung

Increased liver function tests | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum bilirubin increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0877359
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0859062
previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks
Beschreibung

Exubera | Symlin | pramlintide acetate | Byetta | exenatide

Datentyp

boolean

Alias
UMLS CUI [1]
C1176237
UMLS CUI [2]
C1174780
UMLS CUI [3]
C1174779
UMLS CUI [4]
C1636686
UMLS CUI [5]
C0167117
unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
Beschreibung

Diabetes Mellitus Control Unstable | Complications of Diabetes Mellitus Severe | Autonomic neuropathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0259749
exposure to any investigational product(s) in the past 12 weeks
Beschreibung

Exposure to Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
for subjects with type 2 diabetes mellitus: in subjects taking metformin, serum creatinine > 1.4 mg/dl in female subjects and > 1.5 mg/dl in male subjects
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnoses of type 1 or type 2 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Plasma fasting glucose measurement | Glucohemoglobin measurement
Item
fasting plasma glucose (fpg) 80, 140 mg/dl and glycated hemoglobin (a1c) > 6.5% and < or = 10.0%.
boolean
C0583513 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) of < or = 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-smoker | Former smoker | Urine cotinine measurement
Item
non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dl
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C1278256 (UMLS CUI [3])
FEV1 | FEV1 pre bronchodilator Percentage Forced Vital Capacity | FEV1/FVC
Item
forced expiratory volume in 1 second (fev1) = 70% third national health and nutrition examination survey (nhanes iii) predicted; pre-bronchodilator fev1 as a percentage of forced vital capacity (fev1/forced vital capacity(fvc)) = 70%
boolean
C0849974 (UMLS CUI [1])
C0849974 (UMLS CUI [2,1])
C2599602 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C3714541 (UMLS CUI [2,4])
C3815113 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Basal insulin
Item
for subjects with type 2 diabetes mellitus: currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease | Asthma | Lung disease Pulmonary function tests | Lung disease Radiologic finding
Item
history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (pft) and/or radiologic findings
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0024119 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C1290916 (UMLS CUI [4,2])
Increased liver function tests | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum bilirubin increased
Item
elevated liver function test (alanine aminotransferase [alt] or aspartate aminotransferase [ast] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
boolean
C0877359 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0859062 (UMLS CUI [4])
Exubera | Symlin | pramlintide acetate | Byetta | exenatide
Item
previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks
boolean
C1176237 (UMLS CUI [1])
C1174780 (UMLS CUI [2])
C1174779 (UMLS CUI [3])
C1636686 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
Diabetes Mellitus Control Unstable | Complications of Diabetes Mellitus Severe | Autonomic neuropathy
Item
unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
boolean
C0011849 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0342257 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0259749 (UMLS CUI [3])
Exposure to Investigational New Drugs
Item
exposure to any investigational product(s) in the past 12 weeks
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Creatinine measurement, serum | Gender
Item
for subjects with type 2 diabetes mellitus: in subjects taking metformin, serum creatinine > 1.4 mg/dl in female subjects and > 1.5 mg/dl in male subjects
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
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