ID

37316

Beschrijving

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02077452

Link

https://clinicaltrials.gov/show/NCT02077452

Trefwoorden

  1. 16-07-19 16-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 juli 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT02077452

Eligibility Type 2 Diabetes Mellitus NCT02077452

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects with type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
age: 18 to 65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
bmi: 20 to 29 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
mentally, physically and legally eligible to give informed consent.
Beschrijving

Eligibility mental Informed Consent | Eligibility Physical Informed Consent | Eligibility Legal Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0229992
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0205485
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C1301860
UMLS CUI [3,3]
C0021430
willingness to adhere to the protocol requirement.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with type 1 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
episodes of hypoglycemia
Beschrijving

Episodes Hypoglycemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0020615
unstable cardiovascular diseases
Beschrijving

Cardiovascular Diseases Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
hepatic diseases
Beschrijving

Liver diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
kidney disease
Beschrijving

Kidney Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
mental or central nervous system diseases
Beschrijving

Mental disorders | CNS disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0007682
clinical abnormal findings in ecg, labs and physical exams
Beschrijving

ECG abnormal | Laboratory test result abnormal | Physical examination abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0747585

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02077452

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female subjects with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
age: 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi: 20 to 29 kg/m2
boolean
C1305855 (UMLS CUI [1])
Eligibility mental Informed Consent | Eligibility Physical Informed Consent | Eligibility Legal Informed Consent
Item
mentally, physically and legally eligible to give informed consent.
boolean
C1548635 (UMLS CUI [1,1])
C0229992 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1548635 (UMLS CUI [2,1])
C0205485 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C1301860 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Protocol Compliance
Item
willingness to adhere to the protocol requirement.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
subjects with type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Episodes Hypoglycemia
Item
episodes of hypoglycemia
boolean
C0332189 (UMLS CUI [1,1])
C0020615 (UMLS CUI [1,2])
Cardiovascular Diseases Unstable
Item
unstable cardiovascular diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Liver diseases
Item
hepatic diseases
boolean
C0023895 (UMLS CUI [1])
Kidney Disease
Item
kidney disease
boolean
C0022658 (UMLS CUI [1])
Mental disorders | CNS disorder
Item
mental or central nervous system diseases
boolean
C0004936 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
ECG abnormal | Laboratory test result abnormal | Physical examination abnormal
Item
clinical abnormal findings in ecg, labs and physical exams
boolean
C0522055 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0747585 (UMLS CUI [3])

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