Informações:
Falhas:
ID
29226
Descrição
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00698802
Link
https://clinicaltrials.gov/show/NCT00698802
Palavras-chave
Versões (1)
- 09/03/2018 09/03/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
9 de março de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00698802
Eligibility Diabetes NCT00698802
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00698802
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Biphasic Insulins | Antidiabetics Oral | Combined Modality Therapy
Item
current biphasic human insulin (bhi) for at least 3 months - as monotherapy or as the only insulin in combination with oads
boolean
C0356369 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) less than or equal to 40.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c less than or equal to 9.5%
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg (smpg) less than or equal to 12 mmol/l
boolean
C0583513 (UMLS CUI [1])
Insulin IU/kg Daily
Item
treatment with more than 1iu/kg insulin daily
boolean
C0021641 (UMLS CUI [1,1])
C0439463 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0439463 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
GLP-1 Mimetics | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors
boolean
C3273809 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
C2917254 (UMLS CUI [2])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
C0342316 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Investigational New Drugs
Item
receipt of any investigational drug within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results | Shift worker
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0425104 (UMLS CUI [3])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0425104 (UMLS CUI [3])