ID

34700

Descripción

Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT01196546

Link

https://clinicaltrials.gov/show/NCT01196546

Palabras clave

Versiones (1)
  1. 23/1/19 23/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01196546

Inglés

Eligibility Type 2 Diabetes Mellitus NCT01196546

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Metformin U/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0456683
the patient is required to have hba1c 6.5-11.0%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
bmi in the range of 22-48 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe or uncontrolled type 2 diabetes mellitus (hba1c> 11.0%)
Descripción

Non-Insulin-Dependent Diabetes Mellitus Severe | Non-Insulin-Dependent Diabetes Mellitus Uncontrolled | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0474680
acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
Descripción

Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0236013
UMLS CUI [4]
C0009421
congestive heart failure requiring pharmacologic treatment
Descripción

Congestive heart failure Requirement Pharmacotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
Descripción

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
liver disease such as cirrhosis or chronic active hepatitis
Descripción

Liver disease | Liver Cirrhosis | Hepatitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0019189
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01196546

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin U/day
Item
type 2 diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
the patient is required to have hba1c 6.5-11.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi in the range of 22-48 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Severe | Non-Insulin-Dependent Diabetes Mellitus Uncontrolled | Hemoglobin A1c measurement
Item
severe or uncontrolled type 2 diabetes mellitus (hba1c> 11.0%)
boolean
C0011860 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma
Item
acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2])
C0236013 (UMLS CUI [3])
C0009421 (UMLS CUI [4])
Congestive heart failure Requirement Pharmacotherapy
Item
congestive heart failure requiring pharmacologic treatment
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
liver disease such as cirrhosis or chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Volver a la parte superior de la página 

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