ID

33092

Descripción

Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00857870

Link

https://clinicaltrials.gov/show/NCT00857870

Palabras clave

Versiones (1)
  1. 27/11/18 27/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00857870

Inglés

Eligibility Type 2 Diabetes NCT00857870

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
early type 2 diabetes (lower than 5 years known)
Descripción

Non-Insulin-Dependent Diabetes Mellitus Early Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C0872146
male and female(35 to 75 years)
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
hba1c 7 to 8 %, if drug naive and <= 8.5 with previous oad intake
Descripción

Hemoglobin A1c measurement | Pharmaceutical Preparations Absent | Antidiabetics Oral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any treatment more than one oad at the same time
Descripción

Antidiabetics Oral Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
treatment with one oad < 6 weeks time
Descripción

Antidiabetics Oral Quantity Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0449238
insulin treatment
Descripción

Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
acute coronary syndrome < 6 months
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
severe liver disease
Descripción

Liver disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
alcohol abuse or drug addiction
Descripción

Alcohol abuse | Drug Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1510472
severe kidney disease
Descripción

Kidney Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
acute critical illness with renal impairment
Descripción

Critical Illness With Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010340
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1565489
i.v. application of iodine
Descripción

Iodine Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021968
UMLS CUI [1,2]
C1522726
ketoacidosis
Descripción

Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220982
acute or chronic illness witch may lead to hypoxia or cardial failure
Descripción

Illness Causing Hypoxia | Chronic disease Causing Hypoxia | Illness Causing Heart failure | Chronic disease Causing Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0242184
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0242184
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0018801
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0018801
allergy against one of the drugs
Descripción

Hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
deficit in compliance or cooperation
Descripción

Poor compliance | Deficit Cooperation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032646
UMLS CUI [2,1]
C2987487
UMLS CUI [2,2]
C0392337
pregnancy or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women in fertile age without accepted contraceptive
Descripción

Childbearing Potential Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
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Similar models

Eligibility Type 2 Diabetes NCT00857870

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Early Disease length
Item
early type 2 diabetes (lower than 5 years known)
boolean
C0011860 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Age
Item
male and female(35 to 75 years)
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement | Pharmaceutical Preparations Absent | Antidiabetics Oral
Item
hba1c 7 to 8 %, if drug naive and <= 8.5 with previous oad intake
boolean
C0474680 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral Quantity
Item
any treatment more than one oad at the same time
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Antidiabetics Oral Quantity Duration
Item
treatment with one oad < 6 weeks time
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Insulin regime
Item
insulin treatment
boolean
C0557978 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome < 6 months
boolean
C0948089 (UMLS CUI [1])
Liver disease Severe
Item
severe liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Alcohol abuse | Drug Dependence
Item
alcohol abuse or drug addiction
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Kidney Disease Severe
Item
severe kidney disease
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Critical Illness With Renal Insufficiency
Item
acute critical illness with renal impairment
boolean
C0010340 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1565489 (UMLS CUI [1,3])
Iodine Intravenous
Item
i.v. application of iodine
boolean
C0021968 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Ketoacidosis
Item
ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Illness Causing Hypoxia | Chronic disease Causing Hypoxia | Illness Causing Heart failure | Chronic disease Causing Heart failure
Item
acute or chronic illness witch may lead to hypoxia or cardial failure
boolean
C0221423 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0242184 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0242184 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0018801 (UMLS CUI [3,3])
C0008679 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0018801 (UMLS CUI [4,3])
Hypersensitivity Investigational New Drugs
Item
allergy against one of the drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Poor compliance | Deficit Cooperation
Item
deficit in compliance or cooperation
boolean
C0032646 (UMLS CUI [1])
C2987487 (UMLS CUI [2,1])
C0392337 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women in fertile age without accepted contraceptive
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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