ID

16086

Description

Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02235298

Link

https://clinicaltrials.gov/show/NCT02235298

Keywords

Versions (1)
  1. 6/28/16 6/28/16 -
Uploaded on

June 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02235298

English

Eligibility Type 2 Diabetes NCT02235298

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
• type 2 diabetes, as defined by ada criteria
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c ≤ 8% measured at least 1 week prior to the study
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi ≥27 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pre-treatment with metformin as monotherapy
Description

Therapeutic procedure Metformin pre treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C2709094
age > 18 and < 70 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information
Description

Medical contraindication Farxiga

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3700957
type 1 diabetes, as defined by american diabetes association (ada) criteria
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
insulin dependent or treated type 2 diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent Treated

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1522326
current use of other sglt2 inhibitors, glp- 1 analogs or dpp4 inhibitors
Description

Sodium-Glucose Transporter 2 Inhibitors | GLP-1 Analogue | Dipeptidyl Peptidase 4 Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C3665047
UMLS CUI [2]
C3273809
UMLS CUI [3]
C3537161
glomerular filtration rate (gfr) < 60 ml/min/1.73 m2
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
patients with poor glycemic control will be excluded to maximize long-term patient retention without need
Description

Poor glycemic control | patient retention Long-term

Data type

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2,1]
C0679857
UMLS CUI [2,2]
C0443252
history of diabetes ketoacidosis
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
Description

Sign or Symptom Heart failure Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0205082
clinical or laboratory evidences of chronic active liver diseases
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
acute or chronic infective diseases
Description

Acute infectious disease | Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
cancer or chemotherapy
Description

Malignant Neoplasms | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0392920
current use of systemic corticosteroids or in the 3 months prior this study
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
known or suspected allergy to dapaglifozin, excipients, or related products
Description

Hypersensitivity dapagliflozin | Hypersensitivity dapagliflozin Excipient | Hypersensitivity dapagliflozin Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2353951
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2353951
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2353951
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0439849
pregnant, breast-feeding or the intention of becoming pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
females of childbearing potential who are not using adequate contraceptive methods
Description

Childbearing Potential Contraceptive methods Not used

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0445107
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Similar models

Eligibility Type 2 Diabetes NCT02235298

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
• type 2 diabetes, as defined by ada criteria
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≤ 8% measured at least 1 week prior to the study
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Metformin pre treatment
Item
pre-treatment with metformin as monotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Age
Item
age > 18 and < 70 years old
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Farxiga
Item
• known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information
boolean
C1301624 (UMLS CUI [1,1])
C3700957 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes, as defined by american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent Treated
Item
insulin dependent or treated type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Sodium-Glucose Transporter 2 Inhibitors | GLP-1 Analogue | Dipeptidyl Peptidase 4 Inhibitor
Item
current use of other sglt2 inhibitors, glp- 1 analogs or dpp4 inhibitors
boolean
C3665047 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C3537161 (UMLS CUI [3])
Glomerular Filtration Rate
Item
glomerular filtration rate (gfr) < 60 ml/min/1.73 m2
boolean
C0017654 (UMLS CUI [1])
Poor glycemic control | patient retention Long-term
Item
patients with poor glycemic control will be excluded to maximize long-term patient retention without need
boolean
C0342299 (UMLS CUI [1])
C0679857 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Diabetic Ketoacidosis
Item
history of diabetes ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Sign or Symptom Heart failure Severe
Item
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Chronic liver disease
Item
clinical or laboratory evidences of chronic active liver diseases
boolean
C0341439 (UMLS CUI [1])
Acute infectious disease | Chronic infectious disease
Item
acute or chronic infective diseases
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Malignant Neoplasms | Chemotherapy
Item
cancer or chemotherapy
boolean
C0006826 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
systemic steroids
Item
current use of systemic corticosteroids or in the 3 months prior this study
boolean
C2825233 (UMLS CUI [1])
Hypersensitivity dapagliflozin | Hypersensitivity dapagliflozin Excipient | Hypersensitivity dapagliflozin Pharmaceutical Preparations Related
Item
known or suspected allergy to dapaglifozin, excipients, or related products
boolean
C0020517 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2353951 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breast-feeding or the intention of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Not used
Item
females of childbearing potential who are not using adequate contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
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