ID

38841

Beschreibung

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02175121

Link

https://clinicaltrials.gov/show/NCT02175121

Stichworte

Versionen (1)
  1. 08.11.19 08.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT02175121

Englisch

Eligibility Diabetes Mellitus, Type II NCT02175121

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
Beschreibung

Gender | Female infertility | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0001779
body mass index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
Beschreibung

Body mass index | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
hba1c value at the screening visit meeting once of the following criteria:
Beschreibung

Hemoglobin A1c measurement | Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
Beschreibung

Oral hypoglycemic | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0474680
not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
Beschreibung

Oral hypoglycemic Absent | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0474680
fasting plasma glucose concentrations<270mg/dl at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.
Beschreibung

Blood Glucose Self-Monitoring times per day | Subject Diary Maintenance | Study Subject Literacy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0439511
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0024501
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0023864
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus or secondary forms of diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0271640
one or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
Beschreibung

Hypoglycaemic episode Severe Quantity | Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0872291
history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii-iv heart failure, or transient ischemic attach within 6 months of screening.
Beschreibung

Myocardial Infarction | Angina, Unstable | Revascularization Arterial | Cerebrovascular accident | Heart failure New York Heart Association Classification | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0581603
UMLS CUI [3,2]
C0221464
UMLS CUI [4]
C0038454
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1275491
UMLS CUI [6]
C0007787
history or evidence of diabetic complications with significant end organ damage, such as
Beschreibung

Complications of Diabetes Mellitus | End organ damage

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0743496
proliferative retinopathy and/or macular edema;
Beschreibung

Proliferative retinopathy | Macular retinal edema

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0271051
diabetic neuropathy complicated by neuropathic ulcers;
Beschreibung

Diabetic Neuropathy Complicated by Neuropathic ulcer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C0231242
UMLS CUI [1,3]
C0333304
screening seated systolic blood pressure >160 mm hg and/or diastolic blood pressure >100 mm hg after at least a 5 minute seated rest. if the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
Beschreibung

Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes

Datentyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0035253
UMLS CUI [3,3]
C1562039
male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Beschreibung

Gender Partner Pregnancy | Male fertility Contraceptive methods Unwilling | Male fertility Contraceptive methods Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
UMLS CUI [2,1]
C1955321
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1955321
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type II NCT02175121

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Age
Item
male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index | Body Weight
Item
body mass index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Hemoglobin A1c measurement | Criteria Fulfill
Item
hba1c value at the screening visit meeting once of the following criteria:
boolean
C0474680 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Oral hypoglycemic | Hemoglobin A1c measurement
Item
currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
boolean
C0359086 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Oral hypoglycemic Absent | Hemoglobin A1c measurement
Item
not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose concentrations<270mg/dl at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
boolean
C0583513 (UMLS CUI [1])
Blood Glucose Self-Monitoring times per day | Subject Diary Maintenance | Study Subject Literacy
Item
subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.
boolean
C0005803 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0023864 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus
Item
history of type 1 diabetes mellitus or secondary forms of diabetes
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
Hypoglycaemic episode Severe Quantity | Timespan
Item
one or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0872291 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Revascularization Arterial | Cerebrovascular accident | Heart failure New York Heart Association Classification | Transient Ischemic Attack
Item
history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii-iv heart failure, or transient ischemic attach within 6 months of screening.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0581603 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4])
C0018801 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0007787 (UMLS CUI [6])
Complications of Diabetes Mellitus | End organ damage
Item
history or evidence of diabetic complications with significant end organ damage, such as
boolean
C0342257 (UMLS CUI [1])
C0743496 (UMLS CUI [2])
Proliferative retinopathy | Macular retinal edema
Item
proliferative retinopathy and/or macular edema;
boolean
C0339467 (UMLS CUI [1])
C0271051 (UMLS CUI [2])
Diabetic Neuropathy Complicated by Neuropathic ulcer
Item
diabetic neuropathy complicated by neuropathic ulcers;
boolean
C0011882 (UMLS CUI [1,1])
C0231242 (UMLS CUI [1,2])
C0333304 (UMLS CUI [1,3])
Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes
Item
screening seated systolic blood pressure >160 mm hg and/or diastolic blood pressure >100 mm hg after at least a 5 minute seated rest. if the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C1562039 (UMLS CUI [3,3])
Gender Partner Pregnancy | Male fertility Contraceptive methods Unwilling | Male fertility Contraceptive methods Unable
Item
male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C1955321 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1955321 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
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