Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (visit 1)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Antidiabetics Oral | Antidiabetics Oral Absent
Item
stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (oads) treatment). the metformin dose must have been unchanged for at least 3 months prior to screening (visit 1)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Treatment Stable | Sitagliptin Cumulative Dose U/day
Item
stable treatment with a total daily dose of at least 100 mg sitagliptin. the sitagliptin dose must have been unchanged for at least 3 months prior to screening (visit 1)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1565750 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Insulin Absent | Insulin use short-term allowed | Etiology Comorbidity Duration | Etiology Insulin regime Gestational Diabetes
Item
subject is insulin-naïve (never previously treated with insulin). (however, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0240016 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0085207 (UMLS CUI [4,3])
Hemoglobin A1c measurement | Control Inadequate | sitagliptin | Metformin | Antidiabetics Oral | Antidiabetics Oral Absent
Item
hba1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other oads)
boolean
C0474680 (UMLS CUI [1])
C2587213 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C1565750 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Meal Quantity Daily | Breakfast | Dinner
Item
able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C2698559 (UMLS CUI [2])
C4048877 (UMLS CUI [3])
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with thiazolidinedione (tzd) or glucagon-like-peptide-1 (glp-1) receptor agonist within the last 3 months prior to screening (visit 1)
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
Heart Disease | Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
cardiac disease within the last 6 months prior to screening (visit 1), defined as: decompensated heart failure new york heart association (nyha) class iii or iv; unstable angina pectoris; or myocardial infarction
boolean
C0018799 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Hypertension, severe | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Status post Rest Number of minutes
Item
severe hypertension, systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (visit 1)
boolean
C4013784 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C1562039 (UMLS CUI [4,3])
Systemic therapy Medication dose changed | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
boolean
C1515119 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus | Disease Investigational New Drugs At risk
Item
clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011860 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
impaired hepatic function as indicated by aspartate aminotransferase (asat) or alanine aminotransferase (alat) above 2.5 times the upper normal range, according to central laboratory reference ranges
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/l (1.5 mg/dl) for males and equal to or above 124 micromol/l (1.4 mg/dl) for females or estimated creatinine clearance below 60 ml/min, based on the cockroft &
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
ID.15
Item
gault formula and according to local practise for metformin use
boolean