ID

38977

Beschrijving

Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01973231

Link

https://clinicaltrials.gov/show/NCT01973231

Trefwoorden

Versies (1)
  1. 17-11-19 17-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes NCT01973231

Engels

Eligibility Diabetes NCT01973231

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01973231
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
subjects diagnosed with t2dm and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Maximum Tolerated Dose unchanged

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0752079
UMLS CUI [2,3]
C0442739
hba1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) equal to or above 20 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (adequate contraceptive measures as required by local law or practice)
Beschrijving

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness
Beschrijving

Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C0443303
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0009488
history of chronic pancreatitis or idiopathic acute pancreatitis
Beschrijving

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
screening calcitonin value equal to or above 50 ng/l
Beschrijving

Calcitonin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2)
Beschrijving

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl)
Beschrijving

Liver Dysfunction | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula
Beschrijving

Renal Insufficiency | Renal function GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
Beschrijving

Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0002965
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C1320716
heart failure, new york heart association (nyha) class iv
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
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Similar models

Eligibility Diabetes NCT01973231

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01973231
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Maximum Tolerated Dose unchanged
Item
subjects diagnosed with t2dm and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal to or above 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event
Item
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
boolean
C0332189 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
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