ID

37345

Description

Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus.; ODM derived from: https://clinicaltrials.gov/show/NCT02426541

Lien

https://clinicaltrials.gov/show/NCT02426541

Mots-clés

Versions (2)
  1. 19/07/2019 19/07/2019 -
  2. 19/07/2019 19/07/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 juillet 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT02426541

Anglais

Eligibility Type 2 Diabetes Mellitus NCT02426541

1 Formulaires  
Criteria
Description

Criteria

1. provision of signed informed consent prior to any study specific procedures.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
Description

Age | Veins Suitable Cannulation | Veins Suitable Venipuncture Repeated

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0042449
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0917707
UMLS CUI [3,1]
C0042449
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C0600406
UMLS CUI [3,4]
C0205341
3. type 2 diabetes mellitus defined as hba1c of ≥ 6.5% and ≤ 10.5%.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
4. stable (≥ 3 months) t2d treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (dpp-iv)
Description

Treatment Stable Non-Insulin-Dependent Diabetes Mellitus | Metformin | Dipeptidyl-Peptidase IV Inhibitors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1827106
5. body mass index (bmi) ≤ 40 kg/m2.
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
6. female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
Description

Gender | Childbearing Potential Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
1. hysterectomized females
Description

Hysterectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0020699
2. postmenopausal women, defined as women who have not had a menstrual period within 1 year
Description

Postmenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
main exclusion criteria:
Description

Exclusion Criteria Main

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. any condition that is contraindicated with mri such as, but not limited to, having a pacemaker or claustrophobia.
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Claustrophobia

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0008909
2. volume depleted patients. patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
Description

Hypovolemia | Patients At risk Hypovolemia | Cause Comorbidity | Cause Pharmaceutical Preparations | Loop Diuretics | Monitoring Volume Status

Type de données

boolean

Alias
UMLS CUI [1]
C0546884
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0546884
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0009488
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0013227
UMLS CUI [5]
C0354100
UMLS CUI [6,1]
C0150369
UMLS CUI [6,2]
C0005850
UMLS CUI [6,3]
C0449438
3. recent cardiovascular events in a patient:
Description

Cardiovascular event

Type de données

boolean

Alias
UMLS CUI [1]
C1320716
acute coronary syndrome (acs) within 2 months prior to enrolment
Description

Acute Coronary Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0948089
hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
Description

Hospitalization Due to Unstable Angina | Hospitalization Due to Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0002965
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0027051
acute stroke or transient ischemic attack (tia) within two months prior to enrolment
Description

Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
less than two months post coronary artery revascularization
Description

Coronary revascularisation

Type de données

boolean

Alias
UMLS CUI [1]
C0877341
4. congestive heart failure defined as new york heart association (nyha) class iv, unstable or acute congestive heart failure.
Description

Congestive heart failure New York Heart Association Classification | Congestive heart failure Unstable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0443343
5. blood pressure at enrolment: systolic bp ≥165 mm hg and/or diastolic bp ≥100 mm hg
Description

Blood Pressure | Systolic Pressure | Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
6. any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
Description

Illness Clinical Significance | Interventional procedure | Operative Surgical Procedures | Trauma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0543467
UMLS CUI [4]
C3714660
7. on insulin, glp-1 or other oral antidiabetic drug treatment (metformin or both metformin and dpp-iv allowed) or using other medications known to affect glucose metabolism.
Description

Insulin | Glucagon-Like Peptide 1 | Antidiabetics Oral | Metformin allowed | Dipeptidyl-Peptidase IV Inhibitors allowed | Pharmaceutical Preparations Affecting Glucose metabolism

Type de données

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0061355
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C1827106
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0596620
8. any clinically significant abnormalities in physical examination, electrocardiography (ecg) or clinical chemistry results as judged by the investigator. the following specific exclusion criteria apply to the selected clinical chemistry results:
Description

Physical examination abnormal | ECG abnormal | Chemistry abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0747585
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0740327
1. creatinine clearance <60ml/min (estimated with cockroft-gault formula).
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
2. severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (ast) >3x upper limit of normal (uln) and/or alanine aminotransferase (alt) >3x uln.
Description

Hepatic Insufficiency Severe | Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
3. total bilirubin (tb) >2.0 mg/dl (34.2 µmol/l).
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
9. body weight loss greater than 5% within 3 months prior to visit 1.
Description

Weight loss Percentage Timespan

Type de données

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
10. previous pet scan
Description

PET scan

Type de données

boolean

Alias
UMLS CUI [1]
C0032743
11. history of or presence of (as found at visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
Description

Disease Clinical Significance Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Disease Clinical Significance Influence Research results | Medical condition Influence Research results | Disease Clinical Significance Influence Study Subject Participation Status | Medical condition Influence Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C4054723
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C4054723
UMLS CUI [5,4]
C2348568
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C4054723
UMLS CUI [6,3]
C2348568
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02426541

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Informed Consent
Item
1. provision of signed informed consent prior to any study specific procedures.
boolean
C0021430 (UMLS CUI [1])
Age | Veins Suitable Cannulation | Veins Suitable Venipuncture Repeated
Item
2. female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
boolean
C0001779 (UMLS CUI [1])
C0042449 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0917707 (UMLS CUI [2,3])
C0042449 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C0600406 (UMLS CUI [3,3])
C0205341 (UMLS CUI [3,4])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
3. type 2 diabetes mellitus defined as hba1c of ≥ 6.5% and ≤ 10.5%.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Treatment Stable Non-Insulin-Dependent Diabetes Mellitus | Metformin | Dipeptidyl-Peptidase IV Inhibitors
Item
4. stable (≥ 3 months) t2d treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (dpp-iv)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
Body mass index
Item
5. body mass index (bmi) ≤ 40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Gender | Childbearing Potential Absent
Item
6. female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hysterectomy
Item
1. hysterectomized females
boolean
C0020699 (UMLS CUI [1])
Postmenopausal state
Item
2. postmenopausal women, defined as women who have not had a menstrual period within 1 year
boolean
C0232970 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Medical contraindication MRI | Artificial cardiac pacemaker | Claustrophobia
Item
1. any condition that is contraindicated with mri such as, but not limited to, having a pacemaker or claustrophobia.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0008909 (UMLS CUI [3])
Hypovolemia | Patients At risk Hypovolemia | Cause Comorbidity | Cause Pharmaceutical Preparations | Loop Diuretics | Monitoring Volume Status
Item
2. volume depleted patients. patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
boolean
C0546884 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0546884 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0354100 (UMLS CUI [5])
C0150369 (UMLS CUI [6,1])
C0005850 (UMLS CUI [6,2])
C0449438 (UMLS CUI [6,3])
Cardiovascular event
Item
3. recent cardiovascular events in a patient:
boolean
C1320716 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome (acs) within 2 months prior to enrolment
boolean
C0948089 (UMLS CUI [1])
Hospitalization Due to Unstable Angina | Hospitalization Due to Myocardial Infarction
Item
hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0002965 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0027051 (UMLS CUI [2,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
acute stroke or transient ischemic attack (tia) within two months prior to enrolment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Coronary revascularisation
Item
less than two months post coronary artery revascularization
boolean
C0877341 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Congestive heart failure Unstable
Item
4. congestive heart failure defined as new york heart association (nyha) class iv, unstable or acute congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Blood Pressure | Systolic Pressure | Diastolic blood pressure
Item
5. blood pressure at enrolment: systolic bp ≥165 mm hg and/or diastolic bp ≥100 mm hg
boolean
C0005823 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Illness Clinical Significance | Interventional procedure | Operative Surgical Procedures | Trauma
Item
6. any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
Insulin | Glucagon-Like Peptide 1 | Antidiabetics Oral | Metformin allowed | Dipeptidyl-Peptidase IV Inhibitors allowed | Pharmaceutical Preparations Affecting Glucose metabolism
Item
7. on insulin, glp-1 or other oral antidiabetic drug treatment (metformin or both metformin and dpp-iv allowed) or using other medications known to affect glucose metabolism.
boolean
C0021641 (UMLS CUI [1])
C0061355 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C1827106 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0013227 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0596620 (UMLS CUI [6,3])
Physical examination abnormal | ECG abnormal | Chemistry abnormal
Item
8. any clinically significant abnormalities in physical examination, electrocardiography (ecg) or clinical chemistry results as judged by the investigator. the following specific exclusion criteria apply to the selected clinical chemistry results:
boolean
C0747585 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0740327 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
1. creatinine clearance <60ml/min (estimated with cockroft-gault formula).
boolean
C2711451 (UMLS CUI [1])
Hepatic Insufficiency Severe | Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
2. severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (ast) >3x upper limit of normal (uln) and/or alanine aminotransferase (alt) >3x uln.
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Serum total bilirubin measurement
Item
3. total bilirubin (tb) >2.0 mg/dl (34.2 µmol/l).
boolean
C1278039 (UMLS CUI [1])
Weight loss Percentage Timespan
Item
9. body weight loss greater than 5% within 3 months prior to visit 1.
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
PET scan
Item
10. previous pet scan
boolean
C0032743 (UMLS CUI [1])
Disease Clinical Significance Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Disease Clinical Significance Influence Research results | Medical condition Influence Research results | Disease Clinical Significance Influence Study Subject Participation Status | Medical condition Influence Study Subject Participation Status
Item
11. history of or presence of (as found at visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C4054723 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C4054723 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
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