ID

43504

Beskrivning

A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02390050

Länk

https://clinicaltrials.gov/show/NCT02390050

Nyckelord

Versioner (2)
  1. 2015-10-18 2015-10-18 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02390050

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT02390050

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women 20 years of age at screening. women of childbearing potential must test negative by urine pregnancy test.
Beskrivning

age; Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0427780
2. treatment naïve or currently taking one oral anti-diabetic medication in combination with diet and exercise
Beskrivning

anti-diabetic; exercise; diet

Datatyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0012155
3. diagnosed with t2dm with hba1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with hba1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
Beskrivning

Hemoglobin A1c; Diabetes Mellitus Type 2

Datatyp

boolean

Alias
UMLS CUI [1]
C0366781
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441730
4. currently having a body mass index (bmi) ≤ 40 kg/m2
Beskrivning

body mass index (bmi)

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
5. taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
Beskrivning

hyperlipidemia; hypertension; medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0020473
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0013227
6. able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
Beskrivning

Glycemic Index

Datatyp

boolean

Alias
UMLS CUI [1]
C1136206
8. having an hba1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to-5)
Beskrivning

hba1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0366781
9. capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
Beskrivning

Medication dose

Datatyp

boolean

Alias
UMLS CUI [1]
C3174092
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
Beskrivning

diabetes mellitus Type 1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441729
2. current use of parenteral therapy for treatment of diabetes
Beskrivning

diabetes; parenteral therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0259961
3. pregnancy or current breastfeeding status
Beskrivning

pregnancy; Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
4. hemoglobinopathy or carrier status for hemoglobin alleles that affect hba1c measurement
Beskrivning

Hemoglobinopathies

Datatyp

boolean

Alias
UMLS CUI [1]
C0019045
5. genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
Beskrivning

genitourinary tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C1279264
6. estimated glomerular filtration rate (egfr) < 60 ml/min/1.73 m2 at screening.
Beskrivning

glomerular filtration rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0017654
7. uncontrolled hypertension at screening
Beskrivning

uncontrolled hypertension; screening

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C1409616
8. a positive result on hepatitis b surface antigen, hepatitis c, or positive result from screen for drugs of abuse
Beskrivning

Hepatitis B and hepatitis C; Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C2711110
UMLS CUI [2]
C0013146
9. history of human immunodeficiency virus infection
Beskrivning

human immunodeficiency virus infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
10. life expectancy < 2 years
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
11. history of new york heart association class 4 heart failure within 3 months of screening
Beskrivning

new york heart association classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
12. history of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
Beskrivning

myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
13. history of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
14. previous treatment with bexagliflozin or study drug egt0001474
Beskrivning

treatment; drug study

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0008976
15. currently or within 6 months of taking any sodium glucose transporter 2 (sglt2) inhibitors from screening
Beskrivning

Sodium-Glucose Transporter Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C3665045
16. currently participating in another interventional trial
Beskrivning

Interventional Study

Datatyp

boolean

Alias
UMLS CUI [1]
C3274035
17. not able to comply with the study scheduled visits
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
18. affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.
Beskrivning

study; disruption

Datatyp

boolean

Alias
UMLS CUI [1]
C0008972
UMLS CUI [2]
C0332453
19. liver function tests resulting in alanine transaminase (alt) or aspartate transaminase (ast) ≥ 2.5 x upper limit of normal (uln) or total bilirubin ≥ 1.5 x uln, with the exception of isolated gilbert's syndrome ,at screening
Beskrivning

Liver Function Tests

Datatyp

boolean

Alias
UMLS CUI [1]
C0023901
20. exhibiting fasting plasma glucose ≥ 250 mg/dl (13.9 mmol/l) on two or more consecutive days prior to randomization or exhibiting severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
Beskrivning

Plasma fasting glucose measurement; hyperglycemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0020456
21. fasting plasma glucose ≥ 250 mg/dl at randomization
Beskrivning

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
22. prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (uacr) > 2000 mg/g at screening
Beskrivning

Kidney Transplantation; nephrotic syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0027726
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02390050

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age; Pregnancy test negative
Item
1. men or women 20 years of age at screening. women of childbearing potential must test negative by urine pregnancy test.
boolean
C0001779 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
anti-diabetic; exercise; diet
Item
2. treatment naïve or currently taking one oral anti-diabetic medication in combination with diet and exercise
boolean
C0935929 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0012155 (UMLS CUI [3])
Hemoglobin A1c; Diabetes Mellitus Type 2
Item
3. diagnosed with t2dm with hba1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with hba1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
boolean
C0366781 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441730 (UMLS CUI [2,2])
body mass index (bmi)
Item
4. currently having a body mass index (bmi) ≤ 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
hyperlipidemia; hypertension; medication
Item
5. taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
boolean
C0020473 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0013227 (UMLS CUI [3])
informed consent
Item
6. able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
boolean
C0021430 (UMLS CUI [1])
Glycemic Index
Item
7. able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
boolean
C1136206 (UMLS CUI [1])
hba1c
Item
8. having an hba1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to-5)
boolean
C0366781 (UMLS CUI [1])
Medication dose
Item
9. capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
boolean
C3174092 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
diabetes mellitus Type 1
Item
1. a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
diabetes; parenteral therapy
Item
2. current use of parenteral therapy for treatment of diabetes
boolean
C0011849 (UMLS CUI [1])
C0259961 (UMLS CUI [2])
pregnancy; Breast Feeding
Item
3. pregnancy or current breastfeeding status
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hemoglobinopathies
Item
4. hemoglobinopathy or carrier status for hemoglobin alleles that affect hba1c measurement
boolean
C0019045 (UMLS CUI [1])
genitourinary tract infection
Item
5. genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
boolean
C1279264 (UMLS CUI [1])
glomerular filtration rate
Item
6. estimated glomerular filtration rate (egfr) < 60 ml/min/1.73 m2 at screening.
boolean
C0017654 (UMLS CUI [1])
uncontrolled hypertension; screening
Item
7. uncontrolled hypertension at screening
boolean
C1868885 (UMLS CUI [1])
C1409616 (UMLS CUI [2])
Hepatitis B and hepatitis C; Drug abuse
Item
8. a positive result on hepatitis b surface antigen, hepatitis c, or positive result from screen for drugs of abuse
boolean
C2711110 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
human immunodeficiency virus infections
Item
9. history of human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
life expectancy
Item
10. life expectancy < 2 years
boolean
C0023671 (UMLS CUI [1])
new york heart association classification
Item
11. history of new york heart association class 4 heart failure within 3 months of screening
boolean
C1275491 (UMLS CUI [1])
myocardial infarction
Item
12. history of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
boolean
C0027051 (UMLS CUI [1])
Investigational New Drugs
Item
13. history of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer
boolean
C0013230 (UMLS CUI [1])
treatment; drug study
Item
14. previous treatment with bexagliflozin or study drug egt0001474
boolean
C0087111 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Sodium-Glucose Transporter Inhibitors
Item
15. currently or within 6 months of taking any sodium glucose transporter 2 (sglt2) inhibitors from screening
boolean
C3665045 (UMLS CUI [1])
Interventional Study
Item
16. currently participating in another interventional trial
boolean
C3274035 (UMLS CUI [1])
compliance
Item
17. not able to comply with the study scheduled visits
boolean
C1321605 (UMLS CUI [1])
study; disruption
Item
18. affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
Liver Function Tests
Item
19. liver function tests resulting in alanine transaminase (alt) or aspartate transaminase (ast) ≥ 2.5 x upper limit of normal (uln) or total bilirubin ≥ 1.5 x uln, with the exception of isolated gilbert's syndrome ,at screening
boolean
C0023901 (UMLS CUI [1])
Plasma fasting glucose measurement; hyperglycemia
Item
20. exhibiting fasting plasma glucose ≥ 250 mg/dl (13.9 mmol/l) on two or more consecutive days prior to randomization or exhibiting severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
boolean
C0583513 (UMLS CUI [1])
C0020456 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
21. fasting plasma glucose ≥ 250 mg/dl at randomization
boolean
C0583513 (UMLS CUI [1])
Kidney Transplantation; nephrotic syndrome
Item
22. prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (uacr) > 2000 mg/g at screening
boolean
C0022671 (UMLS CUI [1])
C0027726 (UMLS CUI [2])
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