ID

34715

Descripción

Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01387737

Link

https://clinicaltrials.gov/show/NCT01387737

Palabras clave

Versiones (1)
  1. 24/1/19 24/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01387737

Inglés

Eligibility Type 2 Diabetes Mellitus NCT01387737

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women age ≥20 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus at least 3 months before screening
Descripción

Non-Insulin-Dependent Diabetes Mellitus Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
hba1c of ≥7.0% and ≤10.0% (monotherapy group)
Descripción

Hemoglobin A1c measurement | Group Therapy Singular

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205171
hba1c of ≥7.0% and ≤10.5% (combination therapy group)
Descripción

Hemoglobin A1c measurement | Group Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0009429
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0030286
UMLS CUI [3]
C0271640
past or current history of severe diabetic complications
Descripción

Complications of Diabetes Mellitus Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
fasting plasma glucose > 270 mg/dl before treatment start
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
Descripción

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
patients requiring insulin therapy
Descripción

Patient need for Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0557978
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01387737

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women age ≥20 years old
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
diagnosed with type 2 diabetes mellitus at least 3 months before screening
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Group Therapy Singular
Item
hba1c of ≥7.0% and ≤10.0% (monotherapy group)
boolean
C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Hemoglobin A1c measurement | Group Combined Modality Therapy
Item
hba1c of ≥7.0% and ≤10.5% (combination therapy group)
boolean
C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus
Item
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0030286 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
Complications of Diabetes Mellitus Severe
Item
past or current history of severe diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose > 270 mg/dl before treatment start
boolean
C0583513 (UMLS CUI [1])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Patient need for Insulin regime
Item
patients requiring insulin therapy
boolean
C0686904 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
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