ID

33041

Description

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets; ODM derived from: https://clinicaltrials.gov/show/NCT00643851

Link

https://clinicaltrials.gov/show/NCT00643851

Keywords

Versions (2)
  1. 11/24/18 11/24/18 -
  2. 11/24/18 11/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00643851

English

Eligibility Type 2 Diabetes NCT00643851

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0342299
drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
Description

Pharmaceutical Preparations Absent | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0935929
c-peptide ≥ 1.0 ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
body mass index ≤ 45.0 kg/m
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
serum creatinine < 1.50 mg/dl for men or < 1.40 mg/dl for women
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ast and/or alt >3.0 times the upper limit of normal (uln)
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum total bilirubin > 2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatine kinase > 3x the upper limit of normal (uln)
Description

Increased creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C1834662
symptoms of severely uncontrolled diabetes
Description

Symptoms Diabetes mellitus uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0421258
UMLS CUI [1,3]
C0205082
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Description

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

Data type

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 NCT00643851

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control
Item
males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0342299 (UMLS CUI [3])
Pharmaceutical Preparations Absent | Antidiabetics
Item
drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2])
C-peptide measurement
Item
c-peptide ≥ 1.0 ng/ml
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index ≤ 45.0 kg/m
boolean
C1305855 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine < 1.50 mg/dl for men or < 1.40 mg/dl for women
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast and/or alt >3.0 times the upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin > 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Increased creatine kinase
Item
creatine kinase > 3x the upper limit of normal (uln)
boolean
C1834662 (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])
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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