Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection multiple daily | Continuous subcutaneous infusion of insulin
Item
treated with multiple daily insulin injections or csii >= 12 months.
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin Total Daily Dose
Item
current total daily insulin treatment < 1.2 (i)u/kg/day.
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Bolus Insulin Daily
Item
current total daily bolus insulin treatment < 0.7 (i)u/kg/day.
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Bolus Insulin | Insulin Dose During meal
Item
usual insulin bolus dose between 0.8 and 2 (i)u per 10 g ch (both inclusive). expecting prandial insulin dose range for standardised meal test between 5 and 12 (i)u.
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0587120 (UMLS CUI [2,3])
Body mass index
Item
bmi 18.5-28.0 kg/m^2 (both inclusive).
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c <= 9.0% by local laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide <= 0.3 nmol/l.
boolean
C2208720 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to 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])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Study Subject Participation Status | Subject is Randomized
Item
previous participation in this trial. participation is defined as randomised.
boolean
C2348568 (UMLS CUI [1])
C3815594 (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 | Abnormal biochemistry finding | Lipids abnormal | Urine screening abnormal
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])
C0586680 (UMLS CUI [2])
C0549634 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
Gastrointestinal symptom Clinical Significance | Nausea | Vomiting | Heartburn | Diarrhea
Item
presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator.
boolean
C0426576 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0018834 (UMLS CUI [4])
C0011991 (UMLS CUI [5])
Delayed gastric emptying Changing Gastrointestinal Motility | Delayed gastric emptying Changing Food absorption | Gastrointestinal Surgical Procedure Changing Gastrointestinal Motility | Gastrointestinal Surgical Procedure Changing Food absorption
Item
known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
boolean
C0740411 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
C0740411 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699842 (UMLS CUI [2,3])
C0524722 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])
C0524722 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0699842 (UMLS CUI [4,3])
Eating habit Unusual | Special diet Requirement | Clinical Trial Food Unwilling
Item
unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
boolean
C1266864 (UMLS CUI [1,1])
C2700116 (UMLS CUI [1,2])
C0184626 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0016452 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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])