ID

29255

Descripción

Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01464099

Link

https://clinicaltrials.gov/show/NCT01464099

Palabras clave

Versiones (1)
  1. 12/3/18 12/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de marzo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Diabetes NCT01464099

Inglés

Eligibility Diabetes NCT01464099

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01464099
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 1 diabetes treated with insulin for at least 12 months
Descripción

Insulin-Dependent Diabetes Mellitus Disease length | Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0557978
bmi (body mass index) between 18.0-29.0 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
negative fasting c-peptide (below or equal to 0.6 ng/ml)
Descripción

Fasting C-peptide level Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C1513916
hba1c (glycosylated haemoglobin a1c) below or equal to 10.0%
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
current treatment with insulin below or equal to 1.2 u/kg/day
Descripción

Insulin regime Unit/kilogram/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C1532634
subject should be in good health based on medical history, physical examination and routine laboratory data
Descripción

Good health Medical History | Good health Physical Examination | Good health Laboratory Results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3813622
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3813622
UMLS CUI [3,2]
C1254595
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any known/suspected allergies to trial medication or similar products/devices
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Suspected Pharmaceutical Preparations Similar | Hypersensitivity Investigational Medical Device Similar | Hypersensitivity Suspected Investigational Medical Device Similar

Tipo de datos

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]
C0013227
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C2348205
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C2346570
UMLS CUI [5,3]
C2348205
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C2346570
UMLS CUI [6,4]
C2348205
a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
Descripción

Proliferative retinopathy | Disorder of macula of retina | Neuropathy Severe | Autonomic neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0730362
UMLS CUI [3,1]
C0442874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0259749
clinically significant active disease of any kind
Descripción

Disease Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
recurrent major hypoglycemia or hypoglycemic 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
blood donation (more than 500 ml) within the previous 9 weeks
Descripción

Blood Donation Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
Volver a la parte superior de la página

Similar models

Eligibility Diabetes NCT01464099

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01464099
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Insulin regime
Item
subjects with type 1 diabetes treated with insulin for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
Body mass index
Item
bmi (body mass index) between 18.0-29.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Fasting C-peptide level Negative
Item
negative fasting c-peptide (below or equal to 0.6 ng/ml)
boolean
C2208720 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) below or equal to 10.0%
boolean
C0202054 (UMLS CUI [1])
Insulin regime Unit/kilogram/day
Item
current treatment with insulin below or equal to 1.2 u/kg/day
boolean
C0557978 (UMLS CUI [1,1])
C1532634 (UMLS CUI [1,2])
Good health Medical History | Good health Physical Examination | Good health Laboratory Results
Item
subject should be in good health based on medical history, physical examination and routine laboratory data
boolean
C3813622 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C1254595 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Suspected Pharmaceutical Preparations Similar | Hypersensitivity Investigational Medical Device Similar | Hypersensitivity Suspected Investigational Medical Device Similar
Item
any known/suspected allergies to trial medication or similar products/devices
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])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C2346570 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C2346570 (UMLS CUI [6,3])
C2348205 (UMLS CUI [6,4])
Proliferative retinopathy | Disorder of macula of retina | Neuropathy Severe | Autonomic neuropathy
Item
a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2])
C0442874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant active disease of any kind
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Blood Donation Quantity
Item
blood donation (more than 500 ml) within the previous 9 weeks
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial