Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Hypoglycemic Agents Quantity | Exception Thiazolidinediones
Item
1. japanese male or female patients with t2dm treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1257987 (UMLS CUI [6,2])
Glucohemoglobin measurement
Item
2. hemoglobin a1c (hba1c) at screening (visit 1)
boolean
C0202054 (UMLS CUI [1])
Antidiabetics Oral Quantity | Glucohemoglobin measurement
Item
for patients treated with 1 other oral antidiabetic drug: hba1c between 6.5% and 9.0%.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0202054 (UMLS CUI [2])
Antidiabetics Absent | Glucohemoglobin measurement
Item
for patients not treated with any antidiabetic drug: hba1c between 7.0% and 10.0%.
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
Age
Item
3. age between 20 and 70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) between18.0 and 40.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. signed and dated written informed consent before admission to the trial in accordance with the good clinical practice (gcp) and the local legislation.
boolean
C0021430 (UMLS CUI [1])
Antidiabetics | Insulin | Thiazolidinediones | Oral hypoglycemic Quantity
Item
1. antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
boolean
C0935929 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0359086 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Fasting blood glucose measurement | Blood glucose measurement Quantity Washout Period
Item
2. fasted blood glucose of >240 mg/dl (>13.3 mmol/l) or a randomly determined blood glucose level of >400 mg/dl (22.2 mmol/l) on 2 consecutive days during wash-out period.
boolean
C0428568 (UMLS CUI [1])
C0392201 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
3. myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Comorbidity Except Non-Insulin-Dependent Diabetes Mellitus | Hyperlipidemia | Hypertensive disease Treated
Item
4. clinically relevant concomitant diseases other than t2dm, hyperlipidaemia, and medically treated hypertension before the first administration such as
boolean
C0009488 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0020473 (UMLS CUI [2])
C0020538 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
renal insufficiency (calculated estimated glomerular filtration rate <60)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Heart failure New York Heart Association Classification | Cardiovascular Diseases | Hypertensive
Item
cardiac insufficiency of new york heart association (nyha) ii-iv or other known cardiovascular diseases including hypertension of >160/95 mmhg,
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0857121 (UMLS CUI [3])
Nervous system disorder | Epilepsy | Mental disorders
Item
neurological disorders (such as epilepsy) or psychiatric disorders
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Chronic infectious disease | HIV Infection | Hepatitis | Genitourinary tract infection Repeated
Item
acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
boolean
C0151317 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C1279264 (UMLS CUI [4,1])
C0205341 (UMLS CUI [4,2])
Gastrointestinal Diseases | Liver diseases | Respiration Disorders | Endocrine System Diseases | Immune System Diseases
Item
any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
Pharmaceutical Preparations Additional | Exception Pharmaceutical Preparations Specified
Item
5. patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Exception Statins
Item
statins.
boolean
C1705847 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Exception Antihypertensive Agents | Diuretics
Item
antihypertensives (diuretics not allowed)
boolean
C1705847 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
Exception Adrenergic alpha-Antagonists Benign prostatic hypertrophy
Item
alpha-blockers for benign prostate hypertrophy
boolean
C1705847 (UMLS CUI [1,1])
C0001641 (UMLS CUI [1,2])
C1704272 (UMLS CUI [1,3])
Exception Aspirin | Exception Ibuprofen | Exception Acetaminophen
Item
occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
boolean
C1705847 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020740 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Clinical Trial Eligibility Criteria Additional
Item
6. additional inclusion/exclusion criteria apply
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])