ID

22957

Descripción

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE); ODM derived from: https://clinicaltrials.gov/show/NCT00510952

Link

https://clinicaltrials.gov/show/NCT00510952

Palabras clave

  1. 18/6/17 18/6/17 -
Subido en

18 de junio de 2017

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.

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 Mellitus, Type 2 NCT00510952

Eligibility Diabetes Mellitus, Type 2 NCT00510952

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus for at least 1 year.
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
are greater than or equal to 18 years old.
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin-
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025598
sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds)
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3653359
UMLS CUI [1,3]
C1257987
have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0150254
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0726398
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C2114437
are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0009862

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00510952

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
have type 2 diabetes mellitus for at least 1 year.
boolean
C0011860 (UMLS CUI [1])
ID.2
Item
are greater than or equal to 18 years old.
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin-
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
ID.4
Item
sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds)
boolean
C0087111 (UMLS CUI [1,1])
C3653359 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
ID.5
Item
have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
boolean
C0019018 (UMLS CUI [1])
ID.6
Item
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
boolean
C0557978 (UMLS CUI [1])
ID.8
Item
have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
boolean
C0087111 (UMLS CUI [1])
ID.9
Item
have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
boolean
C0150254 (UMLS CUI [1])
ID.10
Item
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
boolean
C0726398 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C2114437 (UMLS CUI [1,3])
ID.11
Item
are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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