Gender | Postmenopausal state | Hysterectomy | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Antidiabetics Oral Quantity | Exception Thiazolidinediones
Item
1. male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
C0012159 (UMLS CUI [5])
C0015259 (UMLS CUI [6])
C0935929 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C1257987 (UMLS CUI [8,2])
Glucohemoglobin measurement
Item
2. glycosylated haemoglobin a1 (hba1c) £ 8.5 % at screening.
boolean
C0202054 (UMLS CUI [1])
Age | Gender | Hysterectomy | Postmenopausal state
Item
3. age >21 and age <70 years (male and hysterectomised female patients) age >60 and age <70 years (postmenopausal female patients)
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Body mass index
Item
4. body mass index (bmi) >18.5 and <40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation
boolean
C0021430 (UMLS CUI [1])
Antidiabetics | Insulin | Thiazolidinediones | Oral hypoglycemic Quantity
Item
1. antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
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 Quantity Washout Period
Item
2. fasted blood glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days during washout.
boolean
C0428568 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
3. glycosylated haemoglobin a1 (hba1c) >8.5% at screening
boolean
C0202054 (UMLS CUI [1])
Comorbidity | Exception Non-Insulin-Dependent Diabetes Mellitus | Exception Hyperlipidemia | Exception Hypertensive disease Treated
Item
4. clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
boolean
C0009488 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020473 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Complications of Diabetes Mellitus Late stage | Retinal Diseases | Polyneuropathy | Nervous system; disorder, vegetative | Diabetic Foot
Item
any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
boolean
C0342257 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2])
C0152025 (UMLS CUI [3])
C1411263 (UMLS CUI [4])
C0206172 (UMLS CUI [5])
Renal Insufficiency | Creatinine clearance measurement
Item
renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Heart insuffiency New York Heart Association Classification | Myocardial Infarction | Cardiovascular Diseases | Hypertensive disease | Cerebrovascular accident | Transient Ischemic Attack
Item
cardiac insufficiency nyha ii-iv, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmhg (measured at training visit and each of the timepoints of day -1), stroke and tia (transistoric ischaemic attack)
boolean
C0392173 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
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])
Communicable Diseases | Chronic infectious disease | HIV Infections | Genitourinary tract infection Repeated
Item
acute or relevant chronic infections (e.g. hiv, repeated urogenital infections)
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (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])
Hypersensitivity | Drug Allergy | Hypersensitivity Pharmaceutical Excipient
Item
5. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
boolean
C0020517 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Prolonged QT interval | Prolonged QTc interval
Item
6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms)
boolean
C0151878 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
Risk factors Additional Torsades de Pointes | Heart failure | Hypokalemia | Family history of sudden death
Item
7. a history of additional risk factors for tdp (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
boolean
C0035648 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2])
C0020621 (UMLS CUI [3])
C2315244 (UMLS CUI [4])