Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Exercise | Antidiabetics Oral | Metformin | Sulfonylurea | Glinides | Combined Modality Therapy
Item
subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5])
C0038766 (UMLS CUI [6])
C3537178 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
Body mass index
Item
bmi between 18.5 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c between 6.5 and 10.0% both inclusive
boolean
C0202054 (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 allergy 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])
Study Subject Participation Status
Item
previous participation in this trial (randomised). re-screening of screening failures is allowed only once
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices Hormonal | Contraceptive implant | Injectable contraception | Condoms, Male | Exception Infertility | Exception Postmenopausal state
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (oc), hormonal intra uterine devices (iuds), implants and injectables; for germany, a condom for the male partner must be used in combination with oc, iud, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
C1657106 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0009653 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0021359 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0232970 (UMLS CUI [11,2])
Investigational New Drugs
Item
the receipt of any investigational drug within 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Insulin regime | Insulin regime short-term allowed
Item
previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening).
boolean
C0557978 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Disease Clinical Significance | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes)
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])
C0012634 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0011860 (UMLS CUI [5,2])
Cardiovascular Disease | Myocardial Infarction | Heart failure
Item
clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the investigator.
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Drug abuse
Item
history of alcoholism or drug abuse during the last 12 months
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Blood Donation | Plasma Donation
Item
blood donation within the last 3 months. plasma donation within the last month.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
Gender Sexually active Contraceptive methods Absent | Condoms, Male | Gender Partner in relationship Pregnancy | Gender Partner in relationship Childbearing Potential
Item
additional exclusion criteria for germany: male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0009653 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C3831118 (UMLS CUI [4,3])