Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
patients with type 2 diabetes for at least one year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Antidiabetics Oral
Item
treated with oral antidiabetic agents (oads) for at least 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C-peptide measurement
Item
baseline c-peptide ≥0.1 nmol/l
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) between 30 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated hemoglobin) < 8.5%
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime
Item
current treatment with insulin
boolean
C0557978 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant and breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Influence Insulin Sensitivity
Item
any medication known to influence insulin sensitivity
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0920563 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current treatment with systemic corticosteroids
boolean
C3653708 (UMLS CUI [1])
Complications Metabolic
Item
history of acute metabolic complications in the past 3 months
boolean
C0009566 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
Recurrent severe hypoglycemia | Hypoglycaemia unawareness
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Proliferative diabetic retinopathy | Diabetic gastroparesis
Item
active proliferative diabetic retinopathy and known diabetic gastroparesis
boolean
C0154830 (UMLS CUI [1])
C0267176 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
impaired hepatic function, as shown but not limited to alt or ast above 2 times the upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Illness Relevant Clinical | Kidney Diseases | Renal Insufficiency | Creatinine clearance measurement
Item
clinically relevant illness such as nephropathy and impaired renal function as shown by clearance < 30 ml/min
boolean
C0221423 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Abnormality Relevant Clinical | Medical condition Relevant Clinical | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Liver disease | Kidney Disease | Metabolic Disease | Hematological Disease | Nervous system disorder | Mental disorder | Systemic disease | Disorder of eye | Communicable Disease | Acute infectious disease Completion of clinical trial Difficult | Acute infectious disease Interpretation Research results Difficult | Acute illness Completion of clinical trial Difficult | Acute illness Interpretation Research results Difficult
Item
any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
boolean
C1704258 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0442893 (UMLS CUI [12])
C0015397 (UMLS CUI [13])
C0009450 (UMLS CUI [14])
C0275518 (UMLS CUI [15,1])
C2732579 (UMLS CUI [15,2])
C0332218 (UMLS CUI [15,3])
C0275518 (UMLS CUI [16,1])
C0459471 (UMLS CUI [16,2])
C0683954 (UMLS CUI [16,3])
C0332218 (UMLS CUI [16,4])
C4061114 (UMLS CUI [17,1])
C2732579 (UMLS CUI [17,2])
C0332218 (UMLS CUI [17,3])
C4061114 (UMLS CUI [18,1])
C0459471 (UMLS CUI [18,2])
C0683954 (UMLS CUI [18,3])
C0332218 (UMLS CUI [18,4])
Insulin allergy | Hypersensitivity Insulin Analog
Item
hypersensitivity to insulins or insulin analogs
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
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 [1,1])
C0518609 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])