ID

17250

Descripción

AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00241605

Link

https://clinicaltrials.gov/show/NCT00241605

Palabras clave

Versiones (1)
  1. 2/9/16 2/9/16 -
Subido en

2 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00241605

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00241605

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients between 18 and 75 years of age with type 2 diabetes mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
Descripción

Age | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Glycaemia control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C3267174
patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
Descripción

Thiazolidinediones stopped | Antidiabetics stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1257987
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1272691
women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
Descripción

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
Descripción

HEPATOCELLULAR REACTION Thiazolidinediones Use | Severe edema Associated with Thiazolidinediones Use

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518991
UMLS CUI [1,2]
C1257987
UMLS CUI [1,3]
C1524063
UMLS CUI [2,1]
C0341950
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1257987
UMLS CUI [2,4]
C1524063
have a known hypersensitivity to thiazolidinediones or biguanides.
Descripción

Hypersensitivity Thiazolidinediones | Hypersensitivity Biguanides

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1257987
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0005382
currently using insulin or any oral anti-diabetic agent other than metformin.
Descripción

Insulin | Oral hypoglycemic | Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0025598
history of metabolic acidosis.
Descripción

Metabolic acidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220981
history of substance abuse.
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
have active cancer other than localized squamous or basal cell carcinoma.
Descripción

Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0392752
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C0392752
chronic disease requiring treatment with corticosteroids.
Descripción

Chronic disease Requirement Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
other criteria will be evaluated at the screening visit.
Descripción

criteria Evaluation Screening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0220908
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00241605

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Glycaemia control
Item
patients between 18 and 75 years of age with type 2 diabetes mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C3267174 (UMLS CUI [3,2])
Thiazolidinediones stopped | Antidiabetics stopped
Item
patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
boolean
C1257987 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods
Item
women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
HEPATOCELLULAR REACTION Thiazolidinediones Use | Severe edema Associated with Thiazolidinediones Use
Item
prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
boolean
C0518991 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0341950 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1257987 (UMLS CUI [2,3])
C1524063 (UMLS CUI [2,4])
Hypersensitivity Thiazolidinediones | Hypersensitivity Biguanides
Item
have a known hypersensitivity to thiazolidinediones or biguanides.
boolean
C0020517 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005382 (UMLS CUI [2,2])
Insulin | Oral hypoglycemic | Metformin
Item
currently using insulin or any oral anti-diabetic agent other than metformin.
boolean
C0021641 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Metabolic acidosis
Item
history of metabolic acidosis.
boolean
C0220981 (UMLS CUI [1])
Substance Use Disorders
Item
history of substance abuse.
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized
Item
have active cancer other than localized squamous or basal cell carcinoma.
boolean
C0006826 (UMLS CUI [1])
C0007137 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
Chronic disease Requirement Adrenal Cortex Hormones
Item
chronic disease requiring treatment with corticosteroids.
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
criteria Evaluation Screening
Item
other criteria will be evaluated at the screening visit.
boolean
C0243161 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
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