Informações:
Falhas:
ID
32697
Descrição
Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study); ODM derived from: https://clinicaltrials.gov/show/NCT00562172
Link
https://clinicaltrials.gov/show/NCT00562172
Palavras-chave
Versões (1)
- 12/11/2018 12/11/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
12 de novembro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00562172
Eligibility Type 2 Diabetes Mellitus NCT00562172
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00562172
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes Mellitus, Non-Insulin-Dependent | Metformin
Item
type 2 diabetes mellitus patients on metformin monotherapy
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0025598 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
7% ≤ hba1c ≤ 12%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
20 kg/m² ≤bmi ≤ 35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus Disease length
Item
diabetes duration: at least 6 months
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus patients
boolean
C0011854 (UMLS CUI [1])
Liver diseases | Alanine aminotransferase increased
Item
clinical evidence of active liver disease, or serum alanine aminotransferase 3 times the upper limit of the normal range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum | Gender
Item
serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis
Item
acute and chronic metabolic acidosis, including diabetic ketoacidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
Substance Use Disorders
Item
history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or not using contraceptive in childbearing aged women
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hypersensitivity Lantus | Sulfonylurea allergy | Metformin allergy
Item
known hypersensitivity to lantus, su or metformin
boolean
C0020517 (UMLS CUI [1,1])
C0876064 (UMLS CUI [1,2])
C0571636 (UMLS CUI [2])
C0571648 (UMLS CUI [3])
C0876064 (UMLS CUI [1,2])
C0571636 (UMLS CUI [2])
C0571648 (UMLS CUI [3])
Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial
Item
any disease or condition that in the opinion of the investigator may interfere with completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])