Diabetes Mellitus, Non-Insulin-Dependent
Item
history of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ada criteria)
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic Absent | Hypoglycemic Agents Injectable Absent
Item
patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline a1c assessment in all patients
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
a1c ≥7.0 % and ≤10.0 %
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasted plasma glucose at screening visit ≤260 mg/dl (14.44 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Antidiabetics Oral | Antidiabetics Injectables
Item
treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
Anti-Obesity Agents | Weight-Loss Agents | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
in the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
boolean
C0376607 (UMLS CUI [1])
C0376606 (UMLS CUI [2])
C3653708 (UMLS CUI [3])
Medical condition Severe compromises Study Subject Participation Status | Mental problem Severe compromises Study Subject Participation Status | Mental disorders Serious Uncontrolled | Major Depressive Disorder | Mental disorders Severe
Item
presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0848067 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C1269683 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Malignant Neoplasms
Item
presence or history of cancer within the past five years
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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 [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])