Gender | Postmenopausal state | Hysterectomy | Diabetes Mellitus, Non-Insulin-Dependent
Item
1. male or postmenopausal or hysterectomised female patients with diagnosis of type 2 diabetes mellitus (t2dm) before informed consent
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
Eligible Arm Number
Item
2. to be eligible for arm 1
boolean
C1548635 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Antidiabetics Oral | Hemoglobin A1c measurement
Item
1. oral antidiabetic mono-therapy for the last 12 weeks prior to informed consent and glycosylated haemoglobin (hba1c) >= 6.5% and <= 8.5% at visit 1a
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Therapy naive | Diabetes Therapy Absent | Hemoglobin A1c measurement
Item
2. therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to informed consent and hba1c >= 7.0% and <= 9.5% at visit 1a.
boolean
C0919936 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Eligible Arm Number
Item
3. to be eligible for arm 2:
boolean
C1548635 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Diabetes Therapy | Metformin Dose Daily | Metformin Dose unchanged | Therapy Stable Willing
Item
a. antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to informed consent and patient´s willingness to keep this therapy stable during the course of the trial and hba1c >= 7.0% and <= 9.5% at visit 1a
boolean
C3274787 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Age | Gender | Hysterectomy
Item
4. age >=18 and <=80 years for female hysterectomised and male patients at visit 1a
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
Age | Postmenopausal state
Item
5. age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at visit 1a
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Body mass index
Item
6. body mass index (bmi) >= 28 and <= 40 kg/m2 at visit 1a
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
7. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and the local legislation
boolean
C0021430 (UMLS CUI [1])
Diabetes Therapy | Exception Antidiabetics Oral | Antidiabetics Oral Quantity
Item
1. treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
boolean
C3274787 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Plasma fasting glucose measurement Confirmed by Fasted Laboratory blood glucose
Item
2. fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
boolean
C0583513 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0430031 (UMLS CUI [1,3])
C0015663 (UMLS CUI [1,4])
Laboratory test result abnormal
Item
3. any laboratory value more than 3 times above upper limit normal (uln) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
boolean
C0438215 (UMLS CUI [1])
Comorbidity | Chronic disease | Exception Non-Insulin-Dependent Diabetes Mellitus | Exception Hyperlipidemia | Exception Hypertensive disease Treated
Item
4. any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
boolean
C0009488 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020473 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020538 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
History of cancer | Cancer treatment
Item
5. medical history of cancer or treatment for cancer in the last five years prior to the visit 1a.
boolean
C0455471 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Cushing Syndrome | Addison Disease | Congenital adrenal hyperplasia | Polycystic Ovary Syndrome
Item
6. history of cushing syndrome, addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
boolean
C0010481 (UMLS CUI [1])
C0001403 (UMLS CUI [2])
C0001627 (UMLS CUI [3])
C0032460 (UMLS CUI [4])
Systemic steroids | inhaled steroids | Steroids Ophthalmologic
Item
7. treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
boolean
C2825233 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0205481 (UMLS CUI [3,2])
Treatment Compliance Abnormal
Item
8. treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
boolean
C4319828 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Pharmaceutical Preparation concomitant
Item
9. use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
boolean
C0013227 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Blood Loss Amount Due to Operative Surgical Procedures | Blood Loss Amount Due to Trauma | Blood Donation Amount | Blood Donation Amount Planned
Item
10. surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3714660 (UMLS CUI [2,4])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0005794 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Other medical condition Interferes with Study Subject Participation Status | Other medical condition At risk Patient safety | Other medical condition At risk Research Personnel | Other medical condition At risk Protocol Compliance | Smoking Habit Interferes with Hospitalization | Alcohol Abstinence Unwilling
Item
11. any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. smoking habits interfering with hospitalization. patients not willing to abstain from alcoholic beverages during inpatient visits
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C4505437 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0019993 (UMLS CUI [5,3])
C0678274 (UMLS CUI [6,1])
C0558080 (UMLS CUI [6,2])
Gender Contraceptive methods Unwilling | Sexual Abstinence | Condoms, Male | Spermatocidal Agents | Oral Contraceptives Partner Female | Sterilization | Intrauterine Devices
Item
12. male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2])
C0009653 (UMLS CUI [3])
C0037862 (UMLS CUI [4])
C0009905 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0086287 (UMLS CUI [5,3])
C0038288 (UMLS CUI [6])
C0021900 (UMLS CUI [7])