ID

33092

Beschrijving

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

Trefwoorden

  1. 27-11-18 27-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 november 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00857870

Eligibility Type 2 Diabetes NCT00857870

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Early Disease length

Datatype

boolean

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

Age

Datatype

boolean

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

Hemoglobin A1c measurement | Pharmaceutical Preparations Absent | Antidiabetics Oral

Datatype

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
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Antidiabetics Oral Quantity

Datatype

boolean

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

Antidiabetics Oral Quantity Duration

Datatype

boolean

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

Insulin regime

Datatype

boolean

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

Acute Coronary Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
severe liver disease
Beschrijving

Liver disease Severe

Datatype

boolean

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

Alcohol abuse | Drug Dependence

Datatype

boolean

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

Kidney Disease Severe

Datatype

boolean

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

Critical Illness With Renal Insufficiency

Datatype

boolean

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

Iodine Intravenous

Datatype

boolean

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

Ketoacidosis

Datatype

boolean

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

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

Datatype

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
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

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

Poor compliance | Deficit Cooperation

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Childbearing Potential Contraceptive methods Absent

Datatype

boolean

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

Similar models

Eligibility Type 2 Diabetes NCT00857870

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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