Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes type 2
boolean
C0011860 (UMLS CUI [1])
NPH insulin | Antidiabetics Oral Dosage Stable | Metformin U/day | Sulfonylurea | Glinides
Item
patients treated nph insulin with stable dosage of oads (oral antidiabetic drugs) for at least 2 months prior to study start and oads treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
boolean
C0021658 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C3537178 (UMLS CUI [5])
Glucohemoglobin measurement | HbA1c measurement (DCCT aligned)
Item
patients must have a hba1c range of >= 4,5% ( 6,2% dcct/diabetes control and complication trials) and <= 8% ( 9,4 % dcct/diabetes control and complication trials)
boolean
C0202054 (UMLS CUI [1])
C1277712 (UMLS CUI [2])
Performance Glucose monitoring system Continuous
Item
ability and willingness to perform continuous glucose monitoring system / cgms (examination within the study)
boolean
C0597198 (UMLS CUI [1,1])
C3873850 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent obtained prior to enrollment in the study
boolean
C0021430 (UMLS CUI [1])
Gender Childbearing Potential Absent | Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Fasting C-peptide level
Item
1. fasting value c peptide <= 400 pmol/l
boolean
C2208720 (UMLS CUI [1])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Progressing Rapidly Unstable
Item
2. active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study.
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0456962 (UMLS CUI [4,3])
C0443343 (UMLS CUI [4,4])
Pregnancy | Pregnancy, Planned
Item
3. pregnant women or women planning gravidity during clinical study protocol
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
4. breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
5. history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE | Therapeutic procedure Influence Glycemia
Item
6. treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
boolean
C3653708 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0005802 (UMLS CUI [2,3])
Requirement Illicit Drugs Probable
Item
7. likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C1514873 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
C0033204 (UMLS CUI [1,3])
Cardiovascular Diseases | Liver diseases | Nervous system disorder | Endocrine System Diseases | Disease Major | Implementation Protocol Difficult | Interpretation Research results Difficult
Item
8. clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C1708476 (UMLS CUI [6,1])
C2348563 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
C0459471 (UMLS CUI [7,1])
C0683954 (UMLS CUI [7,2])
C0332218 (UMLS CUI [7,3])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
9. impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
10. impaired renal function as shown by serum creatinine >/= 133 micromol/l in men and >/= 124 micromol/l in women at study entry
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Substance Use Disorders
Item
11. history of drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
Mental condition Comprehension Study Protocol Unable
Item
12. mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
boolean
C3840291 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Protocol Compliance Unlikely | Uncooperative attitude | Follow-up visit Unable | Completion of clinical trial Unlikely
Item
13. patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2188045 (UMLS CUI [2])
C0589121 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C2732579 (UMLS CUI [4,1])
C0750558 (UMLS CUI [4,2])
Insulin Glargine Specific
Item
14. use of insulin glargine outside the scope of the current spc (summary of product characteristics)
boolean
C0907402 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Study Subject Participation Status
Item
16. patients included in other clinical studies
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])