Diabetes Mellitus
Item
Confirmed diagnosis of t2dm by standard criteria
boolean
C0011860 (UMLS CUI [1])
Drug-naïve patients
Item
Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
boolean
C2054148 (UMLS CUI [1])
Currently untreated patients
Item
Currently untreated patients , who, after the diagnosis of t2dm, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to visit 1
boolean
C0332155 (UMLS CUI [1])
Mono-therapy
Item
Patients being treated with mono-therapy for at least 8 consecutive weeks prior to visit 1 with the following oads: metformin, dipeptidyl peptidase-4 inhibitors (dpp-4i), su, glinide, alpha-glucosidase inhibitor (agi)
boolean
C3274787 (UMLS CUI [1])
Hba1c ≥ 7 to ≤ 10.5%
Item
Hba1c ≥ 7 to ≤ 10.5% at visit 1 for drug-naïve/currently untreated patients
boolean
C0019018 (UMLS CUI [1])
Hba1c ≥ 7 to ≤ 9.5%
Item
Hba1c ≥ 7 to ≤ 9.5% at visit 1 for patients treated with oad monotherapy
boolean
C0019018 (UMLS CUI [1])
Ha1c ≥ 7 to ≤ 10.5%
Item
Hba1c ≥ 7 to ≤ 10.5% at visit 199 for all patients
boolean
Age
Item
Age: ≥18 and ≤ 75 years old at visit 1
boolean
C0001779 (UMLS CUI [1])
Bmi
Item
Bmi ≥22 to ≤45 kg/m2 at visit 1
boolean
C0005893 (UMLS CUI [1])
Fpg ≥270 mg/dl (15 mmol/l)
Item
Fpg ≥270 mg/dl (15 mmol/l) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/l) for patients on oad monotherapy at visit 1
boolean
C0295510 (UMLS CUI [1])
Insulin treatment
Item
Insulin treatment > 4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
boolean
C0745343 (UMLS CUI [1])
Metabolic complications
Item
History of acute metabolic complications, cv disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
boolean
C1393263 (UMLS CUI [1])
Laboratory test result abnormal
Item
Significant lab abnormalities such as tsh outside of normal range, uacr>300 mg/g creatinine, egfr <60 ml/min/1.73m2, hemoglobin <12 g/l in men and <11 g/l in women, hematuria
boolean
C0438215 (UMLS CUI [1])
Ecg abnormalities
Item
Ecg abnormalities including av block, long qt syndrome or qtc>450 msec for men and >470 msec for women
boolean
Malignant Neoplasms
Item
History of malignancy
boolean
C0006826 (UMLS CUI [1])
Child-bearing potential
Item
Women of child-bearing potential not using effective methods of contraception other protocol-defined inclusion/exclusion criteria may apply
boolean
C1960468 (UMLS CUI [1])