Study Subject Therapy naive
Item
subject naïve to treatment
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c > 8.5 up to 11 %
boolean
C0202054 (UMLS CUI [1])
Hypoglycemic Agents Dose Stable | Antihypertensive Agents Dose Stable | Hormone replacement therapy Dose Stable | Thyroid hormone replacement therapy Dose Stable | Contraceptive Agents Dose Stable
Item
lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0282402 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C2242640 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0009871 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Antidiabetics Oral | Insulin
Item
treatment with any oral antidiabetics or insulin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
known type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ketoacidosis
Item
ketoacidosis history
boolean
C0220982 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
history of sensitivity to any of the active substances
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Renal dysfunction | Creatinine measurement, serum | Gender
Item
renal dysfunction : serum creatinine > or = 1.5 mg/dl in male subjects > or = 1.4 mg/dl in female subjects
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Hepatic impairment | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
liver impairment (alt, ast > 3-fold the upper limit of normal range)
boolean
C0948807 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
systemic corticosteroid treatment 3 months prior to study or during the study
boolean
C3653708 (UMLS CUI [1])
Substance Use Disorders
Item
drug or alcohol abuse history
boolean
C0038586 (UMLS CUI [1])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Medical condition compromises Patient safety | Medical condition Study Subject Participation Status Limited | Mental condition compromises Patient safety | Mental condition Study Subject Participation Status Limited | Social Conditions compromise Patient safety | Social Conditions Study Subject Participation Status Limited | Geographic Factors compromise Patient safety | Geographic Factors Study Subject Participation Status Limited
Item
presence of any condition (medical, psychological, social or geographic) current or previously seen that according to investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0037403 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
Neoplasms
Item
neoplasias
boolean
C0027651 (UMLS CUI [1])
Study Subject Participation Status | Aspect 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])
C1879746 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])