ID

23256

Description

Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00394030

Link

https://clinicaltrials.gov/show/NCT00394030

Keywords

Versions (1)
  1. 7/1/17 7/1/17 -
Uploaded on

July 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00394030

English

Eligibility Type 2 Diabetes Mellitus NCT00394030

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
they can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. t2dm subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a tzd (thiazolidinedione).
Description

Healthy Volunteers | Non-Insulin-Dependent Diabetes Mellitus disease length | Antidiabetics Absent | Metformin | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0025598
UMLS CUI [5]
C1257987
subjects must have a bmi between 25 and 40 kg/m² and weigh at least 50kg.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
women must be of non-childbearing potential.
Description

Gender Infertility

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0021359
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dl)
Description

Hematologic Tests Criteria Fulfill | Serum total cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C1445957
clinically significant hepatic enzyme elevation
Description

Elevated liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C0235996
hba1c less than 6.5 or greater than 10
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
positive test result for hepatitis b surface antigen, positive hepatitis c or hiv
Description

Hepatitis B surface antigen positive | Hepatitis C positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
any major illness other than diabetes
Description

Illness Major | Diabetes Mellitus Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C2828389
previous use of insulin as treatment for diabetes
Description

Insulin | Diabetes Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C3274787
significant renal disease as defined by screening lab tests
Description

Kidney Disease Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0022885
history of drug or other allergy which in the opinion of the investigator contradicts subject participation
Description

Drug Allergy Study Subject Participation Status Exclusion | Hypersensitivity Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
smoking or use of nicotine-containing products within the previous 6 months
Description

Tobacco use | Nicotine product

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0028040
history of alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
unwilling to abstain from alcohol prior to and during the in-patient clinic stays
Description

Alcohol Abstinence Unwilling | Inpatient Hospital Stay

Data type

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C3489408
unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
Description

Caffeine product Abstinence Unwilling | Xanthine product Abstinence Unwilling | Inpatient Hospital Stay

Data type

boolean

Alias
UMLS CUI [1,1]
C0006644
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0043314
UMLS CUI [2,2]
C3843422
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0021562
UMLS CUI [3,2]
C3489408
use of st. john's wort during the study
Description

Hypericum perforatum

Data type

boolean

Alias
UMLS CUI [1]
C0936242
has donated 500 nl or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
Description

Blood Donation Blood Dosage | Blood Donation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00394030

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Non-Insulin-Dependent Diabetes Mellitus disease length | Antidiabetics Absent | Metformin | Thiazolidinediones
Item
they can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. t2dm subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a tzd (thiazolidinedione).
boolean
C1708335 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
Body mass index
Item
subjects must have a bmi between 25 and 40 kg/m² and weigh at least 50kg.
boolean
C1305855 (UMLS CUI [1])
Gender Infertility
Item
women must be of non-childbearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hematologic Tests Criteria Fulfill | Serum total cholesterol measurement
Item
bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dl)
boolean
C0018941 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1445957 (UMLS CUI [2])
Elevated liver enzymes
Item
clinically significant hepatic enzyme elevation
boolean
C0235996 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c less than 6.5 or greater than 10
boolean
C0019018 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C positive | HIV Seropositivity
Item
positive test result for hepatitis b surface antigen, positive hepatitis c or hiv
boolean
C0149709 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Illness Major | Diabetes Mellitus Excluded
Item
any major illness other than diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Insulin | Diabetes Therapy
Item
previous use of insulin as treatment for diabetes
boolean
C0021641 (UMLS CUI [1])
C3274787 (UMLS CUI [2])
Kidney Disease Laboratory Procedures
Item
significant renal disease as defined by screening lab tests
boolean
C0022658 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Drug Allergy Study Subject Participation Status Exclusion | Hypersensitivity Study Subject Participation Status Exclusion
Item
history of drug or other allergy which in the opinion of the investigator contradicts subject participation
boolean
C0013182 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Tobacco use | Nicotine product
Item
smoking or use of nicotine-containing products within the previous 6 months
boolean
C0543414 (UMLS CUI [1])
C0028040 (UMLS CUI [2])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Alcohol Abstinence Unwilling | Inpatient Hospital Stay
Item
unwilling to abstain from alcohol prior to and during the in-patient clinic stays
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021562 (UMLS CUI [2,1])
C3489408 (UMLS CUI [2,2])
Caffeine product Abstinence Unwilling | Xanthine product Abstinence Unwilling | Inpatient Hospital Stay
Item
unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
boolean
C0006644 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0043314 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0021562 (UMLS CUI [3,1])
C3489408 (UMLS CUI [3,2])
Hypericum perforatum
Item
use of st. john's wort during the study
boolean
C0936242 (UMLS CUI [1])
Blood Donation Blood Dosage | Blood Donation Planned
Item
has donated 500 nl or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
boolean
C0005794 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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