Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 30 Years to 75 Years
Item
age 30 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has Diabetes Mellitus type 2.
Item
Has Diabetes Mellitus type 2.
boolean
C0011860 (UMLS CUI 2011AA)
A glycosylated hemoglobin level >= 6.5% and < 8.5%.
Item
Hemoglobin, Glycosylated
boolean
C0019018 (UMLS CUI 2011AA)
259689004 (SNOMED CT 2011_0131)
MTHU020323 (LOINC Version 232)
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
Item
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
boolean
C0039798 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Long acting basal insulin analogs
Item
Long acting basal insulin analogs
boolean
C0205112 (UMLS CUI 2011AA)
57195005 (SNOMED CT 2011_0131)
C0304870 (UMLS CUI 2011AA)
25305005 (SNOMED CT 2011_0131)
C0243071 (UMLS CUI 2011AA)
NPH insulin
Item
Neutral protamine hagedorn insulin
boolean
C0021658 (UMLS CUI 2011AA)
66384003 (SNOMED CT 2011_0131)
MTHU019391 (LOINC Version 232)
Combination insulin with 1-2 daily doses except intensified insulin therapies.
Item
Combination insulin with 1-2 daily doses except intensified insulin therapies.
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
A body mass index >= 25.
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Item
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Has a history of type 1 diabetes mellitus.
Item
Has a history of type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI 2011AA)
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
Item
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0585941 (UMLS CUI 2011AA)
308116003 (SNOMED CT 2011_0131)
Has acute infections.
Item
Acute infection
boolean
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
Item
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Has a history of severe or multiple allergies.
Item
Has a history of severe or multiple allergies.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0455609 (UMLS CUI 2011AA)
161614004 (SNOMED CT 2011_0131)
History of drug or alcohol abuse in the past 5 years
Item
History of drug or alcohol abuse in the past 5 years
boolean
C0085762 (UMLS CUI 2011AA)
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, Glomerular Filtration Rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator
Item
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, Glomerular Filtration Rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
History of macular edema.
Item
History of macular edema.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
State after kidney transplantation.
Item
State after kidney transplantation.
boolean
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Serum potassium > 5.5 mmol/L.
Item
Serum Potassium Measurement
boolean
C0302353 (UMLS CUI 2011AA)
271236005 (SNOMED CT 2011_0131)
10040376 (MedDRA 14.1)
History of primary hyperaldosteronism.
Item
History of primary hyperaldosteronism.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1384514 (UMLS CUI 2011AA)
190507007 (SNOMED CT 2011_0131)
10036692 (MedDRA 14.1)
E26.01 (ICD-10-CM Version 2010)
255.12 (ICD-9-CM Version 2011)
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
Item
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
boolean
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
C0189745 (UMLS CUI 2011AA)
2598006 (SNOMED CT 2011_0131)
10048935 (MedDRA 14.1)
C0228174 (UMLS CUI 2011AA)
372073000 (SNOMED CT 2011_0131)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Item
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0013227 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C1360419 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
Pre-treatment with gemfibrozil within the last 12 weeks.
Item
Pre-treatment with gemfibrozil within the last 12 weeks.
boolean
C1882440 (UMLS CUI 2011AA)
C0017245 (UMLS CUI 2011AA)
35282000 (SNOMED CT 2011_0131)
MTHU002557 (LOINC Version 232)
Pre-treatment with rifampicin within the last 12 weeks.
Item
Pre-treatment with rifampicin within the last 12 weeks.
boolean
C1882440 (UMLS CUI 2011AA)
C0035608 (UMLS CUI 2011AA)
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
Treatment with thiazolidinediones within the past 3 months.
Item
Treatment with thiazolidinediones within the past 3 months.
boolean
C0039798 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
If statin therapy applicable: Change of medication within the last 4 weeks.
Item
If statin therapy applicable: Change of medication within the last 4 weeks.
boolean
C0750557 (UMLS CUI 2011AA)
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1706839 (UMLS CUI 2011AA)
C0580105 (UMLS CUI 2011AA)
182838006 (SNOMED CT 2011_0131)
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
Item
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
boolean
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0721444 (UMLS CUI 2011AA)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Treatment with any other investigational drug within 4 weeks before trial entry.
Item
Treatment with any other investigational drug within 4 weeks before trial entry.
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Any elective surgery during study participation.
Item
Any elective surgery during study participation.
boolean
C0206058 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
Item
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
Item
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011175 (UMLS CUI 2011AA)
34095006 (SNOMED CT 2011_0131)
10012174 (MedDRA 14.1)
MTHU020843 (LOINC Version 232)
E86.0 (ICD-10-CM Version 2010)
276.51 (ICD-9-CM Version 2011)
E12258 (CTCAE 1105E)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C1142529 (UMLS CUI 2011AA)
10058705 (MedDRA 14.1)
C0851302 (UMLS CUI 2011AA)
360546002 (SNOMED CT 2011_0131)
10040576 (MedDRA 14.1)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
Acute or scheduled investigation with iodine containing radiopaque material.
Item
Acute or scheduled investigation with iodine containing radiopaque material.
boolean
C0430007 (UMLS CUI 2011AA)
C0021968 (UMLS CUI 2011AA)
325330005 (SNOMED CT 2011_0131)
MTHU009375 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0302587 (UMLS CUI 2011AA)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
Uncontrolled unstable angina pectoris.
Item
Uncontrolled unstable angina pectoris.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
Item
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
C0027059 (UMLS CUI 2011AA)
50920009 (SNOMED CT 2011_0131)
10028606 (MedDRA 14.1)
I51.4 (ICD-10-CM Version 2010)
429.0 (ICD-9-CM Version 2011)
E10157 (CTCAE 1105E)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0003507 (UMLS CUI 2011AA)
60573004 (SNOMED CT 2011_0131)
10002918 (MedDRA 14.1)
C0003486 (UMLS CUI 2011AA)
67362008 (SNOMED CT 2011_0131)
10002882 (MedDRA 14.1)
I71.9 (ICD-10-CM Version 2010)
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