Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus (t2dm) prior to informed consent;
boolean
C0011860 (UMLS CUI [1])
Gender | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Antidiabetics Oral Absent | Insulin Absent
Item
2. male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0021641 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
3. glycosylated haemoglobin a1c (hba1c) >/= 7.0% (53 mmol/mol) to </= 10.0% (86 mmol/mol) at visit 1 (screening);
boolean
C0474680 (UMLS CUI [1])
Age
Item
4. age>/=18 and </=80 years at visit 1(screening);
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
5. body mass index (bmi)</= 45kg/m2 at visit 1 (screening);
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
6. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Hyperglycemia Uncontrolled | Glucose level | Status post Overnight Fasting
Item
1. uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/l) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (not on the same day);
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0439583 (UMLS CUI [3,2])
C0015663 (UMLS CUI [3,3])
Antidiabetics Oral | Insulin
Item
2. treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | ST segment elevation myocardial infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack
Item
3. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris),stroke or transient ischemia attack (tia) within 3 months prior to informed consent;
boolean
C0948089 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
C1536220 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Indication Liver disease | Indication Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
4. indication of liver disease/impaired hepatic function, defined by serum levels of either aspartate aminotransferase (alt or sgpt), alanine aminotransferase (ast or sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined at visit 1 and/or run-in phase,
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0086565 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD | Renal Insufficiency Severe MDRD
Item
5. impaired renal function, defined as egfr< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (mdrd) formula) as determined during screening or at run-in phase
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C3839656 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])
Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic
Item
6. bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption
boolean
C1456587 (UMLS CUI [1])
C0524722 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C3714745 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
History of malignant neoplasm | Exception Basal cell carcinoma | Cancer treatment
Item
7. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
boolean
C0455471 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic
Item
8. blood dyscrasia or any other disorders causing haemolysis or unstable red blood cell (eg. malaria, babesiosis, haemolytic anemia)
boolean
C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019054 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0014792 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])
Pancreatitis | Pancreatitis, Chronic
Item
9. known history of pancreatitis and chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medical contraindication Metformin
Item
10. contraindications to metformin according to the local label
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Anti-Obesity Agents | Treatment Inducing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive
Item
11. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight
boolean
C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3])
C0012159 (UMLS CUI [4,1])
C0580822 (UMLS CUI [4,2])
Systemic steroids | Thyroid Hormones Dosage Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
12. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0014130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0011860 (UMLS CUI [4,2])
Premenopausal state
Item
13. pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
boolean
C0232969 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
1. are nursing or pregnant or
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Implantable subcutaneous contraceptive | Injectable contraception | Sexual Abstinence | Barrier Contraception Double | Partner had vasectomy
Item
2. are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial or who do not agree to continue contraception for at least 30 days after the last dose of study drug. acceptable methods of birth control include tubal ligation, transdermal patch, intra-uterine devices/systems(iuds/iuss), oral, implantable, or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0520483 (UMLS CUI [3])
C2135981 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C3837145 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0004764 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])
C0420842 (UMLS CUI [11])
Substance Use Disorder Interferes with Study Subject Participation Status | Condition Limiting Protocol Compliance
Item
14. alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
15. participation in another trial with application of any investigational drug within 30 days prior to informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Medical condition At risk Patient safety
Item
16. any other clinical condition that would jeopardize patients safety while participating in this trial
boolean
C2348568 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])