ID

33042

Beschrijving

Add-on to Thiazolidinedione (TZD) Failures; ODM derived from: https://clinicaltrials.gov/show/NCT00683878

Link

https://clinicaltrials.gov/show/NCT00683878

Trefwoorden

Versies (1)
  1. 24-11-18 24-11-18 -
Houder van rechten

See clinicltrials.gov

Geüploaded op

24 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes NCT00683878

Engels

Eligibility Type 2 Diabetes NCT00683878

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
Beschrijving

Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0342299
all subjects must have central laboratory pre-randomization a1c ≥ 7.0 and ≤ 10.5%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
Beschrijving

C-peptide measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202100
body mass index ≤ 45.0 kg/m²
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
ast and /or alt > 2.5 times the upper limit of normal
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum total bilirubin > 2 mg/dl (34.2 µmol/l)
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
creatinine kinase > 3.0 times the upper limit of normal
Beschrijving

Elevated creatinine kinase

Datatype

boolean

Alias
UMLS CUI [1]
C1657311
symptoms of severely uncontrolled diabetes
Beschrijving

Symptoms Diabetes mellitus uncontrolled Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0421258
UMLS CUI [1,3]
C0205082
serum creatinine ≥ 2.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
calculated cr-clearance < 50 ml/min (calculated by cockroft-gault formula)
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Beschrijving

Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0442867
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0007222
UMLS CUI [9,2]
C0205404
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205404
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205404
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205404
UMLS CUI [13,1]
C0442867
UMLS CUI [13,2]
C0205404
UMLS CUI [14,1]
C0014130
UMLS CUI [14,2]
C0205404
UMLS CUI [15,1]
C0004936
UMLS CUI [15,2]
C0205404
UMLS CUI [16,1]
C0035435
UMLS CUI [16,2]
C0205404
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Similar models

Eligibility Type 2 Diabetes NCT00683878

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control
Item
males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0342299 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
all subjects must have central laboratory pre-randomization a1c ≥ 7.0 and ≤ 10.5%
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index ≤ 45.0 kg/m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast and /or alt > 2.5 times the upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin > 2 mg/dl (34.2 µmol/l)
boolean
C1278039 (UMLS CUI [1])
Elevated creatinine kinase
Item
creatinine kinase > 3.0 times the upper limit of normal
boolean
C1657311 (UMLS CUI [1])
Symptoms Diabetes mellitus uncontrolled Severe
Item
symptoms of severely uncontrolled diabetes
boolean
C1457887 (UMLS CUI [1,1])
C0421258 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
serum creatinine ≥ 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated cr-clearance < 50 ml/min (calculated by cockroft-gault formula)
boolean
C2711451 (UMLS CUI [1])
Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0442867 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0007222 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205404 (UMLS CUI [10,2])
C0023895 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0018939 (UMLS CUI [12,1])
C0205404 (UMLS CUI [12,2])
C0442867 (UMLS CUI [13,1])
C0205404 (UMLS CUI [13,2])
C0014130 (UMLS CUI [14,1])
C0205404 (UMLS CUI [14,2])
C0004936 (UMLS CUI [15,1])
C0205404 (UMLS CUI [15,2])
C0035435 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
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