Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic
Item
1. subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Age
Item
2. subject is between 18 and 75 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum
Item
3. subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0086839 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
4. if female is of childbearing potential, is practicing a method of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Body mass index
Item
5. subject's bmi is > 18.5 kg/m2 and < 35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Pharmaceutical Preparations chronic | Antihypertensive Agents Dosage Stable | Hypoglycemic Agents Dosage Stable | Thyroid preparations Dosage Stable
Item
6. if on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0020616 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0279175 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Insulin Exogenous GLUCOSE CONTROL
Item
1. subject uses exogenous insulin for glucose control.
boolean
C0021641 (UMLS CUI [1,1])
C0205228 (UMLS CUI [1,2])
C0726398 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
2. subject states that he/she has type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
3. subject states that he/she has a history of diabetic ketoacidosis.
boolean
C0011880 (UMLS CUI [1])
alpha-Glucosidase Inhibitors
Item
4. subject takes an alpha-glucosidase inhibitor.
boolean
C1299007 (UMLS CUI [1])
Communicable Disease | Inpatient Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics
Item
5. subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
boolean
C0009450 (UMLS CUI [1])
C0021562 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
Malignant Neoplasms | Exception Malignant Neoplasms Dermal Specified | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
6. subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0221928 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
Cardiovascular event | Congestive heart failure
Item
7. subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
End-stage Organ failure | Status post Organ Transplantation
Item
8. subject states that he/she has end stage organ failure or is status post organ transplant.
boolean
C0205088 (UMLS CUI [1,1])
C0349410 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0029216 (UMLS CUI [2,2])
Kidney Diseases
Item
9. subject states that he/she has a history of renal disease.
boolean
C0022658 (UMLS CUI [1])
Liver diseases
Item
10. subject states that he/she has current hepatic disease.
boolean
C0023895 (UMLS CUI [1])
Gastroparesis Severe
Item
11. subject states that he/she has a history of severe gastroparesis.
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chronic disease | Communicable Disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
12. subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv.
boolean
C0008679 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Plant Preparations Affecting Blood Glucose | Dietary Supplements Affecting Blood Glucose | Pharmaceutical Preparations Affecting Blood Glucose | Exception Oral hypoglycemic
Item
13. subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
boolean
C0949854 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005802 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0359086 (UMLS CUI [4,2])
Blood Coagulation Disorders
Item
14. subject states that he/she has clotting or bleeding disorders.
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
15. subject is known to be allergic or intolerant to any ingredient found in the study products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])