ID

20680

Descripción

Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00391209

Link

https://clinicaltrials.gov/show/NCT00391209

Palabras clave

Versiones (1)
  1. 10/3/17 10/3/17 -
Subido en

10 de marzo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00391209

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00391209

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus for at least 6 months
Descripción

Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
have a hba1c greater than 7.0% and less than or equal to 10.5% at screening.
Descripción

Glycosylated hemoglobin A Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
patients who have been treated with the following regimen:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
one or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [tzds]),
Descripción

Oral hypoglycemic Quantity Dose Stable | Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2]
C1257987
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
Descripción

Insulin Period Lifetime | Insulin Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C4071830
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1444662
are candidates for insulin therapy, in the opinion of the investigator.
Descripción

Indication Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0557978
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
smoker
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
history of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
Descripción

Hypoglycemia Severe Episode Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
diagnosed with pneumonia in the 3 months prior to screening
Descripción

Pneumonia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032285
patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
Descripción

Glucocorticoids, Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3540777
history of renal transplantation
Descripción

Kidney Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022671
history of lung transplantation
Descripción

Lung Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024128
active or untreated malignancy
Descripción

Malignant Neoplasm | Malignant Neoplasm untreated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332155
treated with incretin mimetics
Descripción

Incretin mimetic product

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1562104
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00391209

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes mellitus for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A Percentage
Item
have a hba1c greater than 7.0% and less than or equal to 10.5% at screening.
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Therapeutic procedure
Item
patients who have been treated with the following regimen:
boolean
C0087111 (UMLS CUI [1])
Oral hypoglycemic Quantity Dose Stable | Thiazolidinediones
Item
one or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [tzds]),
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C1257987 (UMLS CUI [2])
Insulin Period Lifetime | Insulin Discontinued
Item
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
boolean
C0021641 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C4071830 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Indication Insulin regime
Item
are candidates for insulin therapy, in the opinion of the investigator.
boolean
C3146298 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Tobacco use
Item
smoker
boolean
C0543414 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity
Item
history of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Pneumonia
Item
diagnosed with pneumonia in the 3 months prior to screening
boolean
C0032285 (UMLS CUI [1])
Glucocorticoids, Systemic
Item
patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
boolean
C3540777 (UMLS CUI [1])
Kidney Transplantation
Item
history of renal transplantation
boolean
C0022671 (UMLS CUI [1])
Lung Transplantation
Item
history of lung transplantation
boolean
C0024128 (UMLS CUI [1])
Malignant Neoplasm | Malignant Neoplasm untreated
Item
active or untreated malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Incretin mimetic product
Item
treated with incretin mimetics
boolean
C1562104 (UMLS CUI [1])
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