ID

34698

Description

NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01085292

Link

https://clinicaltrials.gov/show/NCT01085292

Keywords

Versions (1)
  1. 1/23/19 1/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01085292

English

Eligibility Type 2 Diabetes Mellitus NCT01085292

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
group a: healthy male and female subjects
Description

Group Roman letter | Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
UMLS CUI [2]
C1708335
group b-d: patients with type 2 diabetes mellitus according to ada definition; gfr > 60 ml/min; hba1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria
Description

Group Roman letter | Diabetes Mellitus, Non-Insulin-Dependent | Glomerular Filtration Rate | Hemoglobin A1c measurement | Albuminuria Normal | Microalbuminuria | Macroalbuminuria

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0017654
UMLS CUI [4]
C0474680
UMLS CUI [5,1]
C0001925
UMLS CUI [5,2]
C0205307
UMLS CUI [6]
C0730345
UMLS CUI [7]
C1654921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of or presence of clinically significant diseases with the exception of diabetes (groups b-d)
Description

Group Roman letter | Disease Clinical Significance | Exception Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011849
concurrent illness that may affect blood glucose other than diabetes
Description

Comorbidity Affecting Blood Glucose | Exception Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005802
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
supine blood pressure at screening, after resting for 5 min, of >140 mmhg systolic or > 90 mmhg diastolic (group a) or > 160 mmhg systolic or > 95 mmhg in diabetes mellitus patients (groups b-d)
Description

Group Roman letter Diabetics | Lying systolic blood pressure Post Rest | Lying diastolic blood pressure Post Rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
UMLS CUI [1,3]
C0241863
UMLS CUI [2,1]
C1319895
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0035253
UMLS CUI [3,1]
C1319896
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0035253
clinically significant abnormal ecg at screening
Description

Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
any kidney disease not caused by diabetes or hypertension
Description

Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0020538
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01085292

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Group Roman letter | Healthy Volunteers
Item
group a: healthy male and female subjects
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2])
Group Roman letter | Diabetes Mellitus, Non-Insulin-Dependent | Glomerular Filtration Rate | Hemoglobin A1c measurement | Albuminuria Normal | Microalbuminuria | Macroalbuminuria
Item
group b-d: patients with type 2 diabetes mellitus according to ada definition; gfr > 60 ml/min; hba1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0001925 (UMLS CUI [5,1])
C0205307 (UMLS CUI [5,2])
C0730345 (UMLS CUI [6])
C1654921 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Group Roman letter | Disease Clinical Significance | Exception Diabetes Mellitus
Item
history of or presence of clinically significant diseases with the exception of diabetes (groups b-d)
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
Comorbidity Affecting Blood Glucose | Exception Diabetes Mellitus
Item
concurrent illness that may affect blood glucose other than diabetes
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Group Roman letter Diabetics | Lying systolic blood pressure Post Rest | Lying diastolic blood pressure Post Rest
Item
supine blood pressure at screening, after resting for 5 min, of >140 mmhg systolic or > 90 mmhg diastolic (group a) or > 160 mmhg systolic or > 95 mmhg in diabetes mellitus patients (groups b-d)
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
C0241863 (UMLS CUI [1,3])
C1319895 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0035253 (UMLS CUI [2,3])
C1319896 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0035253 (UMLS CUI [3,3])
Electrocardiogram abnormal
Item
clinically significant abnormal ecg at screening
boolean
C0522055 (UMLS CUI [1])
Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease
Item
any kidney disease not caused by diabetes or hypertension
boolean
C0022658 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0020538 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
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