ID

38982

Descripción

The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02098395

Link

https://clinicaltrials.gov/show/NCT02098395

Palabras clave

Versiones (1)
  1. 17/11/19 17/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT02098395

Inglés

Eligibility Diabetes NCT02098395

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02098395
Inclusion Criteria
Descripción

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
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged equal to or greater than 18 years at the time of signing informed consent
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to visit 1 (i.e. screening)
Descripción

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treatment with basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to visit 1 (i.e. screening)
Descripción

Basal insulin Bolus | Continuous subcutaneous infusion of insulin | Insulin pump

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
UMLS CUI [2]
C0393124
UMLS CUI [3]
C1140609
stable insulin treatment 3 months or longer prior to visit 1 (i.e. screening), as judged and documented by the investigator
Descripción

Insulin regime Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
hba1c 7.0-10.0 percent (diabetes control and complications trial (dcct)), both inclusive, by central laboratory analysis (visit 1, screening) corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
Descripción

Hemoglobin A1c measurement | HbA1c measurement (DCCT aligned)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C1277712
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dppiv) inhibitors
Descripción

GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C2917254
use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (symlin®)) or affect the subject's safety. premix insulin is not allowed
Descripción

Pharmaceutical Preparations Interfere Glycaemia control | CORTICOSTEROIDS FOR SYSTEMIC USE | Pramlintide | Symlin | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3267174
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0537551
UMLS CUI [4]
C1174780
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1113679
UMLS CUI [6]
C2069057
known proliferative retinopathy or maculopathy requiring acute treatment
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
severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
Descripción

Neuropathy Severe | Autonomic neuropathy | Gastroparesis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0259749
UMLS CUI [3]
C0152020
uncontrolled/untreated blood pressure at screening (visit 1) (after resting for 5 minutes) while sitting greater than 160 mmhg for systolic or greater than 100 mmhg for diastolic (repeated measurement at visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
Descripción

Sitting systolic blood pressure Uncontrolled | Sitting diastolic blood pressure Uncontrolled | Sitting systolic blood pressure Untreated | Sitting diastolic blood pressure Untreated | Status post Rest Number of minutes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0332155
UMLS CUI [4,1]
C1319894
UMLS CUI [4,2]
C0332155
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0035253
UMLS CUI [5,3]
C1562039
history of acute or chronic pancreatitis
Descripción

Pancreatitis | Pancreatitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
screening (visit 1) calcitonin value equal to or greater than 50 ng/l
Descripción

Calcitonin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201924
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Similar models

Eligibility Diabetes NCT02098395

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02098395
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Age
Item
male or female, aged equal to or greater than 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to visit 1 (i.e. screening)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus | Continuous subcutaneous infusion of insulin | Insulin pump
Item
treatment with basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to visit 1 (i.e. screening)
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0393124 (UMLS CUI [2])
C1140609 (UMLS CUI [3])
Insulin regime Stable
Item
stable insulin treatment 3 months or longer prior to visit 1 (i.e. screening), as judged and documented by the investigator
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement | HbA1c measurement (DCCT aligned)
Item
hba1c 7.0-10.0 percent (diabetes control and complications trial (dcct)), both inclusive, by central laboratory analysis (visit 1, screening) corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
boolean
C0474680 (UMLS CUI [1])
C1277712 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dppiv) inhibitors
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Pharmaceutical Preparations Interfere Glycaemia control | CORTICOSTEROIDS FOR SYSTEMIC USE | Pramlintide | Symlin | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin
Item
use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (symlin®)) or affect the subject's safety. premix insulin is not allowed
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
C1174780 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C2069057 (UMLS CUI [6])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Neuropathy Severe | Autonomic neuropathy | Gastroparesis
Item
severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
boolean
C0442874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
Sitting systolic blood pressure Uncontrolled | Sitting diastolic blood pressure Uncontrolled | Sitting systolic blood pressure Untreated | Sitting diastolic blood pressure Untreated | Status post Rest Number of minutes
Item
uncontrolled/untreated blood pressure at screening (visit 1) (after resting for 5 minutes) while sitting greater than 160 mmhg for systolic or greater than 100 mmhg for diastolic (repeated measurement at visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
boolean
C1319893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0035253 (UMLS CUI [5,2])
C1562039 (UMLS CUI [5,3])
Pancreatitis | Pancreatitis, Chronic
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening (visit 1) calcitonin value equal to or greater than 50 ng/l
boolean
C0201924 (UMLS CUI [1])
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