Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c levels ≤ 9.0%
boolean
C0474680 (UMLS CUI [1])
Insulin Total Daily Dose
Item
total insulin dose of < 1.2 u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Body mass index
Item
body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Body Weight
Item
body weight ≤ 125.0 kg
boolean
C0005910 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting serum c-peptide ≤ 1 nmol/l
boolean
C2208720 (UMLS CUI [1])
Insulin regime Stable
Item
treated with a stable insulin regimen for ≥ 3 months prior to screening
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Products Related | Hypersensitivity Suspected Pharmaceutical Products Related
Item
known or suspected allergy to the trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status | Randomization
Item
previous participation in this trial. participation is defined as randomised
boolean
C2348568 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any clinical trial within 3 months prior to this trial
boolean
C2348568 (UMLS CUI [1])
Haematology test abnormal considering Primary disorder | Abnormal biochemistry finding considering Primary disorder | Lipids abnormal considering Primary disorder | Urine screening abnormal considering Primary disorder
Item
clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the investigator considering the underlying disease
boolean
C1112712 (UMLS CUI [1,1])
C0750591 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0586680 (UMLS CUI [2,1])
C0750591 (UMLS CUI [2,2])
C0277554 (UMLS CUI [2,3])
C0549634 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
C0277554 (UMLS CUI [3,3])
C0438142 (UMLS CUI [4,1])
C0750591 (UMLS CUI [4,2])
C0277554 (UMLS CUI [4,3])
Lying systolic blood pressure | Lying diastolic blood pressure | Heart rate supine resting | Antihypertensive Agents
Item
supine blood pressure at screening outside the range of 90-160 mmhg for systolic or 50-95 mmhg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. this exclusion criterion also pertains to subjects being on antihypertensives
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C3262833 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4])
GLP-1 Receptor Agonist | Antidiabetics Oral | Exception Metformin Intake Stable
Item
use of glp-1 receptor agonists or oral antidiabetic drugs (oads) other than stable intake of metformin within 4 weeks prior to screening
boolean
C2917359 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1512806 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Childbearing Potential Contraceptive methods Unwilling
Item
women of child bearing potential, not willing to use contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])