Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day | Sulfonylurea Dose Stable | Gliclazide Maximum Tolerated Dose | Glipizide Maximum Tolerated Dose | Glyburide Maximum Tolerated Dose | Glimepiride Maximum Tolerated Dose
Item
subjects diagnosed with t2dm and treated with metformin equal to or above 1000 mg/day and su (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0017631 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0017642 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0017628 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
C0061323 (UMLS CUI [7,1])
C0752079 (UMLS CUI [7,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal to or above 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Intention Fasting Daytime | Counseling Risk Fasting
Item
subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during ramadan after receiving medical counselling regarding the risk of fasting
boolean
C0162425 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0010210 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0015663 (UMLS CUI [2,3])
Medical contraindication Fasting | Acute illness | Hypoglycemia Severe | Recurrent hypoglycemia | Loss of hypoglycemic warning | Ketoacidosis | Hyperglycemic Hyperosmolar Coma | Exercise With intensity
Item
any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour)
boolean
C1301624 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C4061114 (UMLS CUI [2])
C0020615 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1846288 (UMLS CUI [4])
C0342317 (UMLS CUI [5])
C0220982 (UMLS CUI [6])
C0020457 (UMLS CUI [7])
C0015259 (UMLS CUI [8,1])
C0522510 (UMLS CUI [8,2])
Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula)
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event
Item
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
boolean
C0332189 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])