ID

13527

Description

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

Link

https://clinicaltrials.gov/show/NCT02148250

Keywords

  1. 2/13/16 2/13/16 -
Uploaded on

February 13, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT02148250

Eligibility Type 2 Diabetes NCT02148250

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Diabetes Mellitus Type 2
Description

Diabetes Mellitus

Data type

boolean

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

Age 30-65 years

Data type

boolean

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

A1c

Data type

boolean

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

Insulin treatment

Data type

boolean

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

Non-insulin Hypoglycemic

Data type

boolean

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

Avoid exercise

Data type

boolean

Willing to be fasting for up to 24 hours
Description

Fasting

Data type

boolean

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

Bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Systemic corticosteroids in preceding 3 months
Description

Systemic corticosteroids

Data type

boolean

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

Heavy alcohol consumption

Data type

boolean

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

Alcohol consumption

Data type

boolean

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

Pregnant or actively trying to conceive

Data type

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
Description

Active infection

Data type

boolean

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

Current transplant recipient

Data type

boolean

Alias
UMLS CUI [1]
C0376387

Similar models

Eligibility Type 2 Diabetes NCT02148250

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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