ID

38861

Descripción

Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01074268

Link

https://clinicaltrials.gov/show/NCT01074268

Palabras clave

Versiones (1)
  1. 10/11/19 10/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de noviembre de 2019

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 NCT01074268

Inglés

Eligibility Diabetes NCT01074268

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01074268
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus for at least 12 months
Descripción

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
current treatment with any basal bolus insulin for at least 12 months
Descripción

Basal insulin Bolus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
hba1c below or equal to 10.0%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 35.0 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
for japan only: minimum age is 20 years
Descripción

Japan | Age Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1524031
for the extension trial only: completed the six-month treatment period in trial nn1250-3585 (nct01074268)
Descripción

Extension Trial | Treatment completed Clinical Trial Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0580352
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any other antidiabetic drug than insulin within the last 3 months
Descripción

Antidiabetics | Exception Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
cardiovascular disease within the last 6 months
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled treated/untreated severe hypertension
Descripción

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
Descripción

Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0011880
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Descripción

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer
Descripción

Malignant Neoplasms | History of cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0455471
Volver a la parte superior de la página

Similar models

Eligibility Diabetes NCT01074268

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01074268
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus
Item
current treatment with any basal bolus insulin for at least 12 months
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c below or equal to 10.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Japan | Age Minimum
Item
for japan only: minimum age is 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Extension Trial | Treatment completed Clinical Trial Specified
Item
for the extension trial only: completed the six-month treatment period in trial nn1250-3585 (nct01074268)
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Exception Insulin
Item
use of any other antidiabetic drug than insulin within the last 3 months
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [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