Age
Item
men and women ages 18 to 45 inclusive
boolean
C0001779 (UMLS CUI [1])
Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Laboratory test normal
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0855737 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
C1096215 (UMLS CUI [5])
Body mass index
Item
body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ [height (m)]2
boolean
C1305855 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Illness Significant | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease
Item
current or recent (within 3 months) gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Major surgery
Item
any major surgery within 4 weeks of study drug administration
boolean
C0679637 (UMLS CUI [1])
Glycosuria
Item
glucosuria at screening
boolean
C0017979 (UMLS CUI [1])
Liver function tests abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
abnormal liver functions tests (alt, ast or total bilirubin > 10% above uln)
boolean
C0151766 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Edema Physical Examination
Item
presence of edema on physical exam
boolean
C0013604 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
History of diabetes mellitus
Item
history of diabetes mellitus
boolean
C0455488 (UMLS CUI [1])
Heart failure
Item
history of heart failure
boolean
C0018801 (UMLS CUI [1])
Renal Insufficiency
Item
history of renal insufficiency
boolean
C1565489 (UMLS CUI [1])
Chronic urinary tract infection | Recurrent urinary tract infection | Number of occurrences per year
Item
history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months
boolean
C0262421 (UMLS CUI [1])
C0262655 (UMLS CUI [2])
C0449789 (UMLS CUI [3,1])
C0439508 (UMLS CUI [3,2])
Vulvovaginal mycotic infection Recurrent | Number of occurrences per year | Vulvovaginal mycotic infection
Item
history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
boolean
C1609512 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0449789 (UMLS CUI [2,1])
C0439508 (UMLS CUI [2,2])
C1609512 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance (clcr) of < 80 ml/min using the cockcroft gault formula
boolean
C2711451 (UMLS CUI [1])
Metformin allergy | Intolerance to Metformin | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar
Item
history of allergy or intolerance to metformin or other similar agents
boolean
C0571648 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])