ID

38799

Description

A Study of Multiple Doses of LY2922470 in Participants With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01867216

Link

https://clinicaltrials.gov/show/NCT01867216

Keywords

Versions (1)
  1. 11/4/19 11/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01867216

English

Eligibility Diabetes Mellitus, Type 2 NCT01867216

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
Description

Gender | Female infertility | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0011860
have a glycated hemoglobin (hba1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
Description

Diabetes Therapy unchanged | Exercise | Metformin | Metformin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0442739
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0025598
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0332197
have a screening body mass index (bmi) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Description

Blood Pressure Acceptable | Pulse Rate Acceptable | Blood test result Acceptable | Urine test results Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0232117
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0849535
UMLS CUI [3,2]
C1879533
UMLS CUI [4,1]
C0851020
UMLS CUI [4,2]
C1879533
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently participating in another clinical study or completed one in the last 30 days
Description

Study Subject Participation Status | Clinical Trial Other Completed

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0205197
have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
Description

Heart Disease | Lung disease | Liver disease | Kidney Disease | Stomach Disease | Brain Disease | Medical Problem Causing Risk

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0038354
UMLS CUI [6]
C0006111
UMLS CUI [7,1]
C1254481
UMLS CUI [7,2]
C0678227
UMLS CUI [7,3]
C0035647
have electrocardiogram (ecg) readings that are not suitable for the study
Description

Electrocardiogram Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1548788
are infected with hepatitis b or hepatitis c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
are infected with human immunodeficiency virus (hiv)
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
have donated blood equal to or more than 500 ml within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
Description

Blood Donation Quantity Timespan | Plasma Donation Timespan | Blood Donation Any Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [2,3]
C0872291
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1552551
UMLS CUI [3,3]
C0872291
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01867216

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Diabetes Mellitus, Non-Insulin-Dependent
Item
must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
have a glycated hemoglobin (hba1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
boolean
C0474680 (UMLS CUI [1])
Diabetes Therapy unchanged | Exercise | Metformin | Metformin Absent
Item
do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body mass index
Item
have a screening body mass index (bmi) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Blood Pressure Acceptable | Pulse Rate Acceptable | Blood test result Acceptable | Urine test results Acceptable
Item
have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
boolean
C0005823 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0232117 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0849535 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
C0851020 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Other Completed
Item
are currently participating in another clinical study or completed one in the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Heart Disease | Lung disease | Liver disease | Kidney Disease | Stomach Disease | Brain Disease | Medical Problem Causing Risk
Item
have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0038354 (UMLS CUI [5])
C0006111 (UMLS CUI [6])
C1254481 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0035647 (UMLS CUI [7,3])
Electrocardiogram Inappropriate
Item
have electrocardiogram (ecg) readings that are not suitable for the study
boolean
C0013798 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C
Item
are infected with hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
are infected with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Blood Donation Quantity Timespan | Plasma Donation Timespan | Blood Donation Any Timespan
Item
have donated blood equal to or more than 500 ml within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C0005794 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
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