ID

23354

Descripción

A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00357370

Link

https://clinicaltrials.gov/show/NCT00357370

Palabras clave

Versiones (1)
  1. 3/7/17 3/7/17 -
Subido en

3 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00357370

Inglés

Eligibility Type 2 Diabetes NCT00357370

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0342299
subjects receiving insulin and metformin and/or a thiazolidinedione
Descripción

Insulin | Metformin | Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
body mass index <=45.0 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
serum creatinine <1.5 mg/dl for men or <1.4 mg/dl for women
Descripción

Creatinine measurement, serum | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
no overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)
Descripción

Proteinuria Absent | Albumin To Creatinine Protein Ratio Measurement | Protein measurement, urine, quantitative 24 hour

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0486293
UMLS CUI [3]
C0202204
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
ast and/or alt >2.5 times the upper limit of normal
Descripción

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
creatinine kinase ≥3 times the upper limit of normal
Descripción

Elevated creatine kinase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151576
symptoms of severely uncontrolled diabetes
Descripción

Diabetic - poor control Severe Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0421258
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1457887
history of hypoglycemic unawareness
Descripción

Loss of hypoglycemic warning

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Descripción

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

Tipo de datos

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]
C0006826
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]
C0006826
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 NCT00357370

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control
Item
males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0342299 (UMLS CUI [3])
Insulin | Metformin | Thiazolidinediones
Item
subjects receiving insulin and metformin and/or a thiazolidinedione
boolean
C0021641 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
Body mass index
Item
body mass index <=45.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine <1.5 mg/dl for men or <1.4 mg/dl for women
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Proteinuria Absent | Albumin To Creatinine Protein Ratio Measurement | Protein measurement, urine, quantitative 24 hour
Item
no overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)
boolean
C0033687 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0486293 (UMLS CUI [2])
C0202204 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
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])
Elevated creatine kinase
Item
creatinine kinase ≥3 times the upper limit of normal
boolean
C0151576 (UMLS CUI [1])
Diabetic - poor control Severe Symptoms
Item
symptoms of severely uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Loss of hypoglycemic warning
Item
history of hypoglycemic unawareness
boolean
C0342317 (UMLS CUI [1])
Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant Neoplasms Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant Neoplasms 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])
C0006826 (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])
C0006826 (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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