Glycaemia control Suboptimal | Hemoglobin A1c measurement
Item
have suboptimal glycaemic control as evidenced by an hba1c 7.1% to 10.0%, inclusive
boolean
C3267174 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Body mass index
Item
have a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable
Item
are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start or are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Medical contraindication Antidiabetics Oral
Item
have any contraindication for the oad that they have been using
boolean
C1301624 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
Hypersensitivity Insulin detemir | Hypersensitivity Exenatide | Hypersensitivity Insulin detemir Excipient | Hypersensitivity Exenatide Excipient
Item
have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
boolean
C0020517 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0167117 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0167117 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Systemic Glucocorticoids Oral | Systemic Glucocorticoids Intravenous | Systemic Glucocorticoids Intramuscular | Inhaled steroids Intranasal | Exception Hypopituitarism | Exception Addison Disease
Item
have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (iv) or intramuscular (im) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. addison disease)
boolean
C3540777 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3540777 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3540777 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0442118 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020635 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0001403 (UMLS CUI [6,2])
Weight-Loss Agents
Item
have been treated with drugs that promote weight loss, within 3 months of screening
boolean
C0376606 (UMLS CUI [1])
Insulin | Alpha-glucosidase | Byetta
Item
have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, byetta®
boolean
C0021641 (UMLS CUI [1])
C0002272 (UMLS CUI [2])
C1636686 (UMLS CUI [3])
Exenatide Twice a day | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors
Item
(exenatide bid formulation), thiazolidinediones (tzd), dipeptidyl peptidase (dpp)-4 inhibitors
boolean
C0167117 (UMLS CUI [1,1])
C0585361 (UMLS CUI [1,2])
C1257987 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
Study Subject Participation Status | Completion of clinical trial | Patient withdrawn from trial | Exenatide Once a week
Item
have previously completed or withdrawn from this study or any other study investigating exenatide qw
boolean
C2348568 (UMLS CUI [1])
C2732579 (UMLS CUI [2])
C0422727 (UMLS CUI [3])
C0167117 (UMLS CUI [4,1])
C0558293 (UMLS CUI [4,2])
Pharmaceutical Preparations Approval Lacking
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013227 (UMLS CUI [1,1])
C0162696 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs Off-label | Investigational Medical Device Off-label
Item
are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C2986467 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C2986467 (UMLS CUI [3,2])