Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1])
Metformin | Combined Modality Therapy | Antidiabetics Oral Quantity | Pills Insulin Release | Sulfonylurea | Glinide | DPP-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged
Item
current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other oads including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (tzds) all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0994475 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C1283071 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C3537225 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) no higher than 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
GLP-1 Receptor Agonist
Item
treatment with glucagon-like peptide 1 (glp-1) receptor agonist within the last 12 weeks prior to visit 2
boolean
C2917359 (UMLS CUI [1])
Life threatening illness | Malignant Neoplasms
Item
suffer from a life threatening disease (e.g. cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Pregnancy Serum pregnancy test (B-HCG) | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices, Medicated | Sexual Abstinence | Partner had vasectomy
Item
females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hcg), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal iud, sexual abstinence or vasectomised partner])
boolean
C0032961 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1657106 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021902 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])