Eligibility Diabetes Mellitus, Type 2 NCT01478399

1 moduli

StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 2 NCT01478399

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

males and females age 18 - 79 years of age inclusive.

boolean

C0001779 (UMLS CUI [1])

Body mass index

Item

bmi 19 - 40 kg/m2.

boolean

C1305855 (UMLS CUI [1])

Study Subject Renal Insufficiency | Health Stable | Exception Kidney Disease

Item

renally impaired subjects: in otherwise stable health except for renal disease.

boolean

C0681850 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
C0018684 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0022658 (UMLS CUI [3,2])

Item

healthy volunteers must have/be: egfr as calculated by mdrd of ≥ 80 ml/min, and matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible bmi, race and gender.

boolean

C1708335 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0150103 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
C0001779 (UMLS CUI [4])
C0005910 (UMLS CUI [5])
C1305855 (UMLS CUI [6])
C0034510 (UMLS CUI [7])
C0079399 (UMLS CUI [8])

Study Subject Renal Insufficiency | Estimated Glomerular Filtration Rate Separate Quantity | Stable status Clinical

Item

subjects with renal impairment must have 2 separate egfr that are within 20% of each other and clinically stable for a minimum of 6 months.

boolean

C0681850 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])

Normal Laboratory Test Result | Admission Evaluation Normal | Exception Test Result Consistent with Renal Insufficiency | Exception Test Result Consistent with Kidney Disease

Item

no clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the investigator.

boolean

C0438214 (UMLS CUI [1])
C0582948 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0456984 (UMLS CUI [3,2])
C0332290 (UMLS CUI [3,3])
C1565489 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0456984 (UMLS CUI [4,2])
C0332290 (UMLS CUI [4,3])
C0022658 (UMLS CUI [4,4])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

GLP-1 Receptor Agonist | Byetta | Victoza

Item

currently taking or have taken a glp -1 agent (e.g., byetta®, victoza®) within the past year.

boolean

C2917359 (UMLS CUI [1])
C1636686 (UMLS CUI [2])
C2732208 (UMLS CUI [3])

Other Coding | GLP-1 Analogue Specified

Item

subjects who have previously received pb1023.

boolean

C3846158 (UMLS CUI [1])
C3273809 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])

Hypersensitivity GLP-1 Analogue | Adverse effect Serious GLP-1 Analogue | Hypersensitivity GLP-1 Receptor Agonist | Adverse effect Serious GLP-1 Receptor Agonist

Item

known allergy or serious adverse effect to an approved or investigational glp-1 receptor analog/agonist.

boolean

C0020517 (UMLS CUI [1,1])
C3273809 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3273809 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2917359 (UMLS CUI [3,2])
C0879626 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2917359 (UMLS CUI [4,3])

Communicable Disease Serious

Item

serious infection within 60 days of admission.

boolean

C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])

Blood Donation Amount | Blood Loss Amount

Item

donation or loss of greater than 400 ml of blood 56 days prior to enrollment.

boolean

C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])

Cardiovascular Disease Unstable

Item

unstable cardiovascular disease defined as per protocol.

boolean

C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])

Liver Dysfunction

Item

clinically significant hepatic dysfunction defined as per protocol.

boolean

C0086565 (UMLS CUI [1])

Pregnancy | Trying to conceive | Breast Feeding

Item

female subjects who are pregnant, trying to become pregnant or lactating.

boolean

C0032961 (UMLS CUI [1])
C0420843 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Substance Use Disorders | Substance Abuse Screening Positive

Item

known history of or active alcohol or drug abuse within 12 months prior to screening or positive alcohol and/or drug screen.

boolean

C0038586 (UMLS CUI [1])
C0038577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])

HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Item

positive for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies.

boolean

C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Exception Observational Study | Study Subject Participation Status Interferes with Research results

Item

participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the investigator would interfere with the outcome of the study.

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1518527 (UMLS CUI [4,2])
C2348568 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])

Ritorna all'inizio della pagina

ID

Descrizione

collegamento

Keywords

versioni (1)

Titolare del copyright

Caricato su

DOI

Licenza

Commenti del modello :

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Eligibility Diabetes Mellitus, Type 2 NCT01478399