ID

33040

Beskrivning

Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00683657

Länk

https://clinicaltrials.gov/show/NCT00683657

Nyckelord

  1. 2018-11-24 2018-11-24 -
Rättsinnehavare

See clinicaltrial.gov

Uppladdad den

24 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Type 2 Diabetes NCT00683657

Eligibility Type 2 Diabetes NCT00683657

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥18- and ≤77-years-old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
taking metformin immediate release (ir) or xr ≥1500 mg for at least 8 weeks as monotherapy
Beskrivning

Metformin Immediate Release | Metformin Extended Release

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C1707968
glycosylated hemoglobin (a1c) ≥7% and ≤10%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) ≤40 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential unable or unwilling to use acceptable birth control
Beskrivning

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
women who are pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant cardiovascular history
Beskrivning

Cardiovascular History

Datatyp

boolean

Alias
UMLS CUI [1]
C1880008
active liver disease
Beskrivning

Liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
renal impairment
Beskrivning

Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489

Similar models

Eligibility Type 2 Diabetes NCT00683657

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥18- and ≤77-years-old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Immediate Release | Metformin Extended Release
Item
taking metformin immediate release (ir) or xr ≥1500 mg for at least 8 weeks as monotherapy
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C1707968 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (a1c) ≥7% and ≤10%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential unable or unwilling to use acceptable birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular History
Item
significant cardiovascular history
boolean
C1880008 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
renal impairment
boolean
C1565489 (UMLS CUI [1])

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