ID

35782

Beschrijving

Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02453555

Link

https://clinicaltrials.gov/show/NCT02453555

Trefwoorden

Versies (1)
  1. 22-03-19 22-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02453555

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02453555

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of t2dm prior to informed consent
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
2. male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
Beschrijving

Diet therapy | Exercise

Datatype

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
1 drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent, or
Beschrijving

Antidiabetics Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
2 pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent, for linagliptin 5 mg at least 16 weeks prior to visit 1). individual antidiabetic drug (except linagliptin) will have to be discontinued at visit 1.
Beschrijving

Antidiabetics Oral Quantity | Sulfonylurea | Antidiabetics Dose Stable | Thiazolidinediones unchanged | Linagliptin Dose | Antidiabetics Specific To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0038766
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1257987
UMLS CUI [4,2]
C0442739
UMLS CUI [5,1]
C2746078
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0935929
UMLS CUI [6,2]
C0205369
UMLS CUI [6,3]
C1272691
3. hba1c at visit 1
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
1 hba1c =8.0% and =10.5% for patients who are drug-naïve, or
Beschrijving

Hemoglobin A1c measurement | Pharmaceutical Preparations Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
2 hba1c =7.5% and =10.5% for patients with one oral antidiabetic drug (except linagliptin), or
Beschrijving

Hemoglobin A1c measurement | Antidiabetics Oral Quantity | Exception Linagliptin

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2746078
3 hba1c =7.5% and =10.0% for patients with linagliptin 5 mg
Beschrijving

Hemoglobin A1c measurement | Linagliptin Dose

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C2746078
UMLS CUI [2,2]
C0178602
4. hba1c =7.5% and =10.0% at visit 4 for randomisation into the double-blind treatment period. patient who are pre-treated with linagliptin 5 mg for 16 weeks or more prior to visit 1 and meet the criteria of hba1c can directly move on to the run-in (visit 4).
Beschrijving

Hemoglobin A1c measurement | Randomization Double-Blind Method

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0013072
5. age =20 years at informed consent
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
6. bmi =40.0 kg/m2 at visit 1 (screening)
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
7. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice (gcp) and local legislation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15.0 mmol/l) after an overnight fast during the open-label stabilisation period (from visit 2 to visit 4) and run-in period (from visit 4 to visit 5) , confirmed by a second measurement (not on the same day and done either at the central or at local laboratory).
Beschrijving

Hyperglycemia Uncontrolled | Glucose level Post Overnight Fasting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0428548
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0439583
UMLS CUI [2,4]
C0015663
2. acute coronary syndrome (st-elevation myocardial infarction [stemi], non-stemi, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent
Beschrijving

Acute Coronary Syndrome | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C1536220
UMLS CUI [3]
C1561921
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
3. indication of liver disease, defined by serum levels of either alanine aminotransferase (alt [sgpt]), aspartate aminotransferase (ast [sgot]), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln) as determined during screening, open-label stabilisation period and/or run-in period
Beschrijving

Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
4. impaired renal function, defined as estimated glomerular filtration rate (egfr) <45 ml/min/1.73 m2 (mdrd formula) as determined during screening, open-label stabilisation period and/or run-in period
Beschrijving

Renal Insufficiency | Renal function GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
5. known hereditary galactose intolerance
Beschrijving

Galactosemia Hereditary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016952
UMLS CUI [1,2]
C0439660
6. known contraindications to linagliptin and empagliflozin according to the japanese label
Beschrijving

Medical contraindication Linagliptin | Medical contraindication Empagliflozin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2746078
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C3490348
7. any previous (within 2 years prior to informed consent) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induce chronic malabsorption
Beschrijving

Bariatric Surgery | Bariatric Surgery Planned | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C1456587
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0524722
UMLS CUI [3,2]
C0205263
UMLS CUI [3,3]
C3714745
UMLS CUI [3,4]
C0205191
8. medical history of cancer (except for resected non-invasive basal cell or squamous carcinoma) and/or treatment for cancer within the last 5 years
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma Resected | Exception Squamous cell carcinoma Resected | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1521996
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007137
UMLS CUI [3,3]
C1521996
UMLS CUI [4]
C0920425
9. known blood dyscrasias or any disorders causing haemolysis or unstable red blood cell (rbc) count (e.g. malaria, babesiosis, haemolytic anaemia).
Beschrijving

Hematological Disease | Disease Causing Hemolysis | Disease Causing Red Blood Cell Count Unstable | Malaria | Babesiosis | Anemia, Hemolytic

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0019054
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0014772
UMLS CUI [3,4]
C0443343
UMLS CUI [4]
C0024530
UMLS CUI [5]
C0004576
UMLS CUI [6]
C0002878
10. treatment with insulin, glp-1 agonists, within 12 weeks prior to informed consent
Beschrijving

Insulin regime | GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C2917359
11. treatment with anti-obesity drugs within 12 weeks 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
Beschrijving

Anti-Obesity Agents | Therapeutic procedure Causing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive

Datatype

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0005910
UMLS CUI [2,4]
C0443343
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0012159
UMLS CUI [4,2]
C0580822
12. current treatment with systemic steroids (other than inhaled or topical steroids) at informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm
Beschrijving

Systemic steroids | Exception Inhaled steroids | Exception Topical steroids | Thyroid Hormones Dose Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2065041
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2064827
UMLS CUI [4,1]
C0040135
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0392747
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0011860
13. pre-menopausal women (last menstruation =1 year prior to informed consent) who:
Beschrijving

Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
1 are nursing or pregnant or
Beschrijving

Breast Feeding | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include tubal ligation, intra uterine devices/systems, oral contraceptives, complete sexual abstinence, double barrier method and vasectomised partner
Beschrijving

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Tubal Ligation | Intrauterine Devices | Intrauterine System | Contraceptives, Oral | Sexual Abstinence | Barrier Contraception Double | Partner had vasectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0520483
UMLS CUI [4]
C0021900
UMLS CUI [5]
C4293370
UMLS CUI [6]
C0009905
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C0420842
14. known or suspected allergy or hypersensitivity to trial products or related products (e.g., dpp-4 inhibitors or sglt-2 inhibitors)
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Product Related | Hypersensitivity Suspected Product Related | Hypersensitivity Dipeptidyl Peptidase-4 Inhibitor | Hypersensitivity Suspected Dipeptidyl Peptidase-4 Inhibitor | Hypersensitivity SGLT2 Inhibitor | Hypersensitivity Suspected SGLT2 Inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C1514468
UMLS CUI [4,4]
C0439849
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C3537225
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C3537225
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C3273807
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0750491
UMLS CUI [8,3]
C3273807
15. alcohol or drug abuse within the 12 weeks prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to trial procedures or trial drug intake, by the judgment of the investigator
Beschrijving

Substance Use Disorder Interferes with Study Subject Participation Status | Condition Decreasing Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0442797
UMLS CUI [2,3]
C0525058
16. intake of an investigational drug in another trial within 30 days prior to visit 1 or participation in the follow-up period of another trial (participation in observational studies is permitted)
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Clinical Study Follow-up | Observational Study allowed

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C3274571
UMLS CUI [4,1]
C1518527
UMLS CUI [4,2]
C0683607
17. any other clinical condition that, in the opinion of the investigator, would jeopardize patient¿s safety while participating in this clinical trial
Beschrijving

Other medical condition compromises Patient safety | Relationship Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C2348568
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02453555

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of t2dm prior to informed consent
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise
Item
2. male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
Antidiabetics Absent
Item
1 drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent, or
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Sulfonylurea | Antidiabetics Dose Stable | Thiazolidinediones unchanged | Linagliptin Dose | Antidiabetics Specific To be stopped
Item
2 pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent, for linagliptin 5 mg at least 16 weeks prior to visit 1). individual antidiabetic drug (except linagliptin) will have to be discontinued at visit 1.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C2746078 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0935929 (UMLS CUI [6,1])
C0205369 (UMLS CUI [6,2])
C1272691 (UMLS CUI [6,3])
Glycosylated hemoglobin A
Item
3. hba1c at visit 1
boolean
C0019018 (UMLS CUI [1])
Hemoglobin A1c measurement | Pharmaceutical Preparations Absent
Item
1 hba1c =8.0% and =10.5% for patients who are drug-naïve, or
boolean
C0474680 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Antidiabetics Oral Quantity | Exception Linagliptin
Item
2 hba1c =7.5% and =10.5% for patients with one oral antidiabetic drug (except linagliptin), or
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2746078 (UMLS CUI [3,2])
Hemoglobin A1c measurement | Linagliptin Dose
Item
3 hba1c =7.5% and =10.0% for patients with linagliptin 5 mg
boolean
C0474680 (UMLS CUI [1])
C2746078 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Randomization Double-Blind Method
Item
4. hba1c =7.5% and =10.0% at visit 4 for randomisation into the double-blind treatment period. patient who are pre-treated with linagliptin 5 mg for 16 weeks or more prior to visit 1 and meet the criteria of hba1c can directly move on to the run-in (visit 4).
boolean
C0474680 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
Age
Item
5. age =20 years at informed consent
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
6. bmi =40.0 kg/m2 at visit 1 (screening)
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
7. 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])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level Post Overnight Fasting
Item
1. uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15.0 mmol/l) after an overnight fast during the open-label stabilisation period (from visit 2 to visit 4) and run-in period (from visit 4 to visit 5) , confirmed by a second measurement (not on the same day and done either at the central or at local laboratory).
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0439583 (UMLS CUI [2,3])
C0015663 (UMLS CUI [2,4])
Acute Coronary Syndrome | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack
Item
2. acute coronary syndrome (st-elevation myocardial infarction [stemi], non-stemi, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent
boolean
C0948089 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
3. indication of liver disease, defined by serum levels of either alanine aminotransferase (alt [sgpt]), aspartate aminotransferase (ast [sgot]), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln) as determined during screening, open-label stabilisation period and/or run-in period
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
4. impaired renal function, defined as estimated glomerular filtration rate (egfr) <45 ml/min/1.73 m2 (mdrd formula) as determined during screening, open-label stabilisation period and/or run-in period
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Galactosemia Hereditary
Item
5. known hereditary galactose intolerance
boolean
C0016952 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Medical contraindication Linagliptin | Medical contraindication Empagliflozin
Item
6. known contraindications to linagliptin and empagliflozin according to the japanese label
boolean
C1301624 (UMLS CUI [1,1])
C2746078 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C3490348 (UMLS CUI [2,2])
Bariatric Surgery | Bariatric Surgery Planned | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic
Item
7. any previous (within 2 years prior to informed consent) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induce chronic malabsorption
boolean
C1456587 (UMLS CUI [1])
C1456587 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0524722 (UMLS CUI [3,1])
C0205263 (UMLS CUI [3,2])
C3714745 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
Malignant Neoplasms | Exception Basal cell carcinoma Resected | Exception Squamous cell carcinoma Resected | Cancer treatment
Item
8. medical history of cancer (except for resected non-invasive basal cell or squamous carcinoma) and/or treatment for cancer within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1521996 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
C0920425 (UMLS CUI [4])
Hematological Disease | Disease Causing Hemolysis | Disease Causing Red Blood Cell Count Unstable | Malaria | Babesiosis | Anemia, Hemolytic
Item
9. known blood dyscrasias or any disorders causing haemolysis or unstable red blood cell (rbc) count (e.g. malaria, babesiosis, haemolytic anaemia).
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])
C0014772 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])
Insulin regime | GLP-1 Receptor Agonist
Item
10. treatment with insulin, glp-1 agonists, within 12 weeks prior to informed consent
boolean
C0557978 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
Anti-Obesity Agents | Therapeutic procedure Causing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive
Item
11. treatment with anti-obesity drugs within 12 weeks 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])
C0678227 (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 | Exception Inhaled steroids | Exception Topical steroids | Thyroid Hormones Dose Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
12. current treatment with systemic steroids (other than inhaled or topical steroids) at 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])
C1705847 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2064827 (UMLS CUI [3,2])
C0040135 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
C0014130 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0011860 (UMLS CUI [6,2])
Premenopausal state
Item
13. pre-menopausal women (last menstruation =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 | Intrauterine Devices | Intrauterine System | Contraceptives, Oral | 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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include tubal ligation, intra uterine devices/systems, oral contraceptives, complete sexual abstinence, double barrier method and vasectomised 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])
C0021900 (UMLS CUI [4])
C4293370 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0420842 (UMLS CUI [9])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Product Related | Hypersensitivity Suspected Product Related | Hypersensitivity Dipeptidyl Peptidase-4 Inhibitor | Hypersensitivity Suspected Dipeptidyl Peptidase-4 Inhibitor | Hypersensitivity SGLT2 Inhibitor | Hypersensitivity Suspected SGLT2 Inhibitor
Item
14. known or suspected allergy or hypersensitivity to trial products or related products (e.g., dpp-4 inhibitors or sglt-2 inhibitors)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C1514468 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C3537225 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C3537225 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C3273807 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C3273807 (UMLS CUI [8,3])
Substance Use Disorder Interferes with Study Subject Participation Status | Condition Decreasing Protocol Compliance
Item
15. alcohol or drug abuse within the 12 weeks prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to trial procedures or trial drug intake, by the judgment of the investigator
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0442797 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs | Clinical Study Follow-up | Observational Study allowed
Item
16. intake of an investigational drug in another trial within 30 days prior to visit 1 or participation in the follow-up period of another trial (participation in observational studies is permitted)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C3274571 (UMLS CUI [3])
C1518527 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Other medical condition compromises Patient safety | Relationship Study Subject Participation Status
Item
17. any other clinical condition that, in the opinion of the investigator, would jeopardize patient¿s safety while participating in this clinical trial
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0439849 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
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