ID

13527

Beskrivning

PK/PD STUDY OF U-500 REGULAR INSULIN; ODM derived from: https://clinicaltrials.gov/show/NCT02148250

Länk

https://clinicaltrials.gov/show/NCT02148250

Nyckelord

  1. 2016-02-13 2016-02-13 -
Uppladdad den

13 februari 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT02148250

Eligibility Type 2 Diabetes NCT02148250

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Diabetes Mellitus Type 2
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
Age 30-65 years
Beskrivning

Age 30-65 years

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
A1c between 7-9.5% within the past month
Beskrivning

A1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
On >200 units of insulin per day (>150 units if also on oral/glp-1 agents)
Beskrivning

Insulin treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0745343
willing to discontinue oral/injectable non-insulin hypoglycemic agents for minimum of 1 week prior to study
Beskrivning

Non-insulin Hypoglycemic

Datatyp

boolean

Alias
UMLS CUI [1]
C2825234
Willing to avoid exercise 48 hours prior to study
Beskrivning

Avoid exercise

Datatyp

boolean

Willing to be fasting for up to 24 hours
Beskrivning

Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Bmi between 25 and 38 kg/m2
Beskrivning

Bmi

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
Systemic corticosteroids in preceding 3 months
Beskrivning

Systemic corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C4039704
heavy alcohol consumption (>21 drinks/week men, >14 drinks/week women)
Beskrivning

Heavy alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1]
C2030272
Unwillingness to stop alcohol consumption for 24 hours before each study visit
Beskrivning

Alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
Pregnant or actively trying to conceive
Beskrivning

Pregnant or actively trying to conceive

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0420843
Current diagnosis of active infection, cancer (other than basal cell carcinoma), vascular disease, organ failure
Beskrivning

Active infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0042373
UMLS CUI [4]
C0349410
Current transplant recipient
Beskrivning

Current transplant recipient

Datatyp

boolean

Alias
UMLS CUI [1]
C0376387

Similar models

Eligibility Type 2 Diabetes NCT02148250

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus
Item
Diabetes Mellitus Type 2
boolean
C0011860 (UMLS CUI [1])
Age 30-65 years
Item
Age 30-65 years
boolean
C0001779 (UMLS CUI [1])
A1c
Item
A1c between 7-9.5% within the past month
boolean
C0019018 (UMLS CUI [1])
Insulin treatment
Item
On >200 units of insulin per day (>150 units if also on oral/glp-1 agents)
boolean
C0745343 (UMLS CUI [1])
Non-insulin Hypoglycemic
Item
willing to discontinue oral/injectable non-insulin hypoglycemic agents for minimum of 1 week prior to study
boolean
C2825234 (UMLS CUI [1])
Avoid exercise
Item
Willing to avoid exercise 48 hours prior to study
boolean
Fasting
Item
Willing to be fasting for up to 24 hours
boolean
C0015663 (UMLS CUI [1])
Bmi
Item
Bmi between 25 and 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic corticosteroids
Item
Systemic corticosteroids in preceding 3 months
boolean
C4039704 (UMLS CUI [1])
Heavy alcohol consumption
Item
heavy alcohol consumption (>21 drinks/week men, >14 drinks/week women)
boolean
C2030272 (UMLS CUI [1])
Alcohol consumption
Item
Unwillingness to stop alcohol consumption for 24 hours before each study visit
boolean
C0001948 (UMLS CUI [1])
Pregnant or actively trying to conceive
Item
Pregnant or actively trying to conceive
boolean
C0549206 (UMLS CUI [1])
C0420843 (UMLS CUI [2])
Active infection
Item
Current diagnosis of active infection, cancer (other than basal cell carcinoma), vascular disease, organ failure
boolean
C0009450 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0042373 (UMLS CUI [3])
C0349410 (UMLS CUI [4])
Current transplant recipient
Item
Current transplant recipient
boolean
C0376387 (UMLS CUI [1])

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