Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes for at least 1 year
boolean
C0011860 (UMLS CUI [1])
Insulin naive
Item
insulin naïve
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Antidiabetics Oral Dose Stable | Metformin U/day
Item
treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Glycosylated hemoglobin A Percentage
Item
7% ≤ hba1c ≤ 10.5 %
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) < 40 kg/m²
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring Blood glucose meter Able | Blood Glucose Self-Monitoring Blood glucose meter Willing | Subject Diary Use Able | Subject Diary Use Willing
Item
ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
boolean
C0005803 (UMLS CUI [1,1])
C0472226 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0005803 (UMLS CUI [2,1])
C0472226 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C3890583 (UMLS CUI [3,1])
C0457083 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
C3890583 (UMLS CUI [4,1])
C0457083 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin | Therapeutic procedure Gestational Diabetes | Insulin Therapeutic procedure Brief
Item
current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
boolean
C0021641 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1879313 (UMLS CUI [3,3])
Glucagon-Like Peptide-1 Receptor agonists | Dipeptidyl-Peptidase IV Inhibitors
Item
treatment with glucagon-like peptide (glp)-1 receptor agonists or with dipeptidyl peptidase (dpp)-iv inhibitors
boolean
C0378073 (UMLS CUI [1,1])
C0243192 (UMLS CUI [1,2])
C1827106 (UMLS CUI [2])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable Rapidly progressive | Slit lamp fundus examination
Item
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1838681 (UMLS CUI [4,3])
C1444586 (UMLS CUI [5])
Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Breast Feeding
Item
breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
treatment with systemic corticosteroids in the 3 months prior to study entry
boolean
C3653708 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any investigational product in the 2 months prior to study entry
boolean
C0013230 (UMLS CUI [1])
Probability Illicit drug use Patient need for
Item
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0033204 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Disease Major Protocol Compliance Difficulty | Disease Major Research results Difficulty
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0332218 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
C0332218 (UMLS CUI [6,4])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function as shown by serum creatinine ≥ 1.5 mg/dl (≥ 133 μmol/l) in men and ≥ 1.4 mg/dl (124 μmol/l) in women at study entry
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Substance Use Disorders
Item
history of drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
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])