ID

32862

Description

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00831779

Link

https://clinicaltrials.gov/show/NCT00831779

Keywords

Versions (1)
  1. 11/17/18 11/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00831779

English

Eligibility Type 2 Diabetes Mellitus NCT00831779

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 7.0 and ≤ 10.0% at the enrollment visit
Description

Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0342299
UMLS CUI [3]
C0474680
subjects should have been receiving either metformin therapy or metformin therapy and one insulin secretagogue for at least 12 weeks prior to enrollment
Description

Metformin | Pills Insulin Release

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0994475
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C1283071
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
bmi ≤ 45.0 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
urine albumin to creatinine ratio (uacr) > 1,800 mg/g (203.4 mg/mmol/cr)
Description

Urine albumin/creatinine ratio measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455271
aspartate aminotransferase (ast) > 3x upper limit of normal (uln)
Description

Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
alanine aminotransferase (alt) > 3x uln
Description

Alanine aminotransferase increased

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
μmol/l) for women
Description

ID.10

Data type

boolean

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 Mellitus NCT00831779

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control | Hemoglobin A1c measurement
Item
subjects with type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 7.0 and ≤ 10.0% at the enrollment visit
boolean
C0011860 (UMLS CUI [1])
C0342299 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Metformin | Pills Insulin Release
Item
subjects should have been receiving either metformin therapy or metformin therapy and one insulin secretagogue for at least 12 weeks prior to enrollment
boolean
C0025598 (UMLS CUI [1])
C0994475 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1283071 (UMLS CUI [2,3])
C-peptide measurement
Item
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
bmi ≤ 45.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Urine albumin/creatinine ratio measurement
Item
urine albumin to creatinine ratio (uacr) > 1,800 mg/g (203.4 mg/mmol/cr)
boolean
C0455271 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
aspartate aminotransferase (ast) > 3x upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine aminotransferase (alt) > 3x uln
boolean
C0151905 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin > 2 mg/dl (34.2 μmol/l)
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
ID.10
Item
μmol/l) for women
boolean
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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