ID

34292

Description

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function; ODM derived from: https://clinicaltrials.gov/show/NCT02014259

Link

https://clinicaltrials.gov/show/NCT02014259

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT02014259

Eligibility Diabetes NCT02014259

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02014259
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 18-85 years (both inclusive) at the time of signing inform consent
Description

ID.1

Data type

boolean

subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
Description

ID.2

Data type

boolean

for subject with normal renal function: good general health (as judged by the investigator)
Description

ID.3

Data type

boolean

body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
Description

ID.5

Data type

boolean

history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Description

ID.6

Data type

boolean

uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
Description

ID.7

Data type

boolean

any blood draw or donation of blood or plasma in excess of 400 ml within the 3 months preceding the screening visit (visit 2)
Description

ID.8

Data type

boolean

history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
Description

ID.9

Data type

boolean

Similar models

Eligibility Diabetes NCT02014259

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02014259
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female aged 18-85 years (both inclusive) at the time of signing inform consent
boolean
ID.2
Item
subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
boolean
ID.3
Item
for subject with normal renal function: good general health (as judged by the investigator)
boolean
ID.4
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
boolean
ID.6
Item
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
boolean
ID.7
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
ID.8
Item
any blood draw or donation of blood or plasma in excess of 400 ml within the 3 months preceding the screening visit (visit 2)
boolean
ID.9
Item
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
boolean

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