ID

17250

Description

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

Link

https://clinicaltrials.gov/show/NCT00241605

Keywords

Versions (1)
  1. 9/2/16 9/2/16 -
Uploaded on

September 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00241605

English

Eligibility Diabetes Mellitus, Type 2 NCT00241605

1 forms  
Inclusion Criteria
Description

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).
Description

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

Data type

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.
Description

Thiazolidinediones stopped | Antidiabetics stopped

Data type

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.
Description

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods

Data type

boolean

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

Exclusion Criteria

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

HEPATOCELLULAR REACTION Thiazolidinediones Use | Severe edema Associated with Thiazolidinediones Use

Data type

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.
Description

Hypersensitivity Thiazolidinediones | Hypersensitivity Biguanides

Data type

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.
Description

Insulin | Oral hypoglycemic | Metformin

Data type

boolean

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

Metabolic acidosis

Data type

boolean

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

Substance Use Disorders

Data type

boolean

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

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

Data type

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.
Description

Chronic disease Requirement Adrenal Cortex Hormones

Data type

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.
Description

criteria Evaluation Screening

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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