ID

38942

Descripción

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT01620489

Link

https://clinicaltrials.gov/show/NCT01620489

Palabras clave

Versiones (1)
  1. 14/11/19 14/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01620489

Inglés

Eligibility Diabetes NCT01620489

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620489
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: monotherapy or any duo-combinations of metformin and/or sus and/or pioglitazone. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. or monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin | Sulfonylurea | pioglitazone | Combined Modality Therapy | Kidney Failure Moderate | Basal insulin | Premixed insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C3274787
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0071097
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0035078
UMLS CUI [7,2]
C0205081
UMLS CUI [8]
C0650607
UMLS CUI [9]
C2069057
hba1c 7-10% (both inclusive)
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an egfr (glomerular filtration rate) of 30-59 ml/min/1.73 m2 per mdrd (modification of diet in renal disease) formula at the screening visit
Descripción

Renal Insufficiency Moderate | Renal function GFR estimation by MDRD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C2170215
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Descripción

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
Descripción

Antidiabetics | Exception Inclusion criteria | Insulin regime short-term allowed | Insulin, Short-Acting | Relationship Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0443303
UMLS CUI [3,3]
C0683607
UMLS CUI [4]
C0356365
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0009488
impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal limit
Descripción

Liver Dysfunction | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
history of chronic pancreatitis or idiopathic acute pancreatitis
Descripción

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
within the past 180 days any of the following: episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ecg (electrocardiogram))
Descripción

Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event | Arrhythmia by ECG Finding | Conduction delay ECG

Tipo de datos

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
UMLS CUI [6]
C3831474
UMLS CUI [7,1]
C1398354
UMLS CUI [7,2]
C1623258
heart failure defined as new york heart association (nyha) class iv
Descripción

Heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
a systolic blood pressure above or equal to 180 mmhg or a diastolic blood pressure above or equal to 100 mmhg
Descripción

Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
Descripción

RENAL DISEASE PROGRESSIVE Rapidly | Acute glomerulonephritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748293
UMLS CUI [1,2]
C0456962
UMLS CUI [2]
C0156221
use of immunosuppressive treatment within 90 days prior to screening
Descripción

Therapeutic immunosuppression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021079
diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
Descripción

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
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Similar models

Eligibility Diabetes NCT01620489

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620489
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin | Sulfonylurea | pioglitazone | Combined Modality Therapy | Kidney Failure Moderate | Basal insulin | Premixed insulin
Item
subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: monotherapy or any duo-combinations of metformin and/or sus and/or pioglitazone. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. or monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
boolean
C0011860 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0071097 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C0035078 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C0650607 (UMLS CUI [8])
C2069057 (UMLS CUI [9])
Hemoglobin A1c measurement
Item
hba1c 7-10% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Renal Insufficiency Moderate | Renal function GFR estimation by MDRD
Item
moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an egfr (glomerular filtration rate) of 30-59 ml/min/1.73 m2 per mdrd (modification of diet in renal disease) formula at the screening visit
boolean
C1565489 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Antidiabetics | Exception Inclusion criteria | Insulin regime short-term allowed | Insulin, Short-Acting | Relationship Comorbidity
Item
treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0356365 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0009488 (UMLS CUI [5,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event | Arrhythmia by ECG Finding | Conduction delay ECG
Item
within the past 180 days any of the following: episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ecg (electrocardiogram))
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])
C3831474 (UMLS CUI [6])
C1398354 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
Heart failure New York Heart Association Classification
Item
heart failure defined as new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
a systolic blood pressure above or equal to 180 mmhg or a diastolic blood pressure above or equal to 100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
RENAL DISEASE PROGRESSIVE Rapidly | Acute glomerulonephritis
Item
rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
boolean
C0748293 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0156221 (UMLS CUI [2])
Therapeutic immunosuppression
Item
use of immunosuppressive treatment within 90 days prior to screening
boolean
C0021079 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
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