ID

38977

Description

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

Keywords

Versions (1)
  1. 11/17/19 11/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01973231

English

Eligibility Diabetes NCT01973231

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01973231
Inclusion Criteria
Description

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
Description

Informed Consent

Data type

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
Description

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

Data type

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)
Description

Hemoglobin A1c measurement

Data type

boolean

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

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

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)
Description

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

Data type

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
Description

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

Data type

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
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

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

Calcitonin measurement

Data type

boolean

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

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

Data type

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)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

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
Description

Renal Insufficiency | Renal function GFR estimation by MDRD

Data type

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
Description

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

Data type

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
Description

Heart failure New York Heart Association Classification

Data type

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)
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

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)
Description

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

Data type

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 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01973231
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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