ID

37341

Description

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02380521

Link

https://clinicaltrials.gov/show/NCT02380521

Keywords

Versions (1)
  1. 7/18/19 7/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02380521

English

Eligibility Type 2 Diabetes Mellitus NCT02380521

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. men and women with t2dm aged >18 years;
Description

Diabetes Mellitus, Non-Insulin-Dependent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0001779
3. bmi >25 kg/m2;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. hba1c 7.5-8.5 %;
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
5. receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
Description

Metformin Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or willingness to become pregnant;
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
2. moderate and severe liver dysfunction;
Description

Liver Dysfunction Moderate | Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
3. moderate and severe renal failure;
Description

RENAL FAILURE MODERATE | Kidney Failure Severe

Data type

boolean

Alias
UMLS CUI [1]
C0748307
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C0205082
4. previous major cardiovascular event;
Description

Cardiovascular event Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
5. severe infections at the discretion of the investigator (such as human immunodeficiency virus [hiv], hepatitis b virus [hbv] and hepatitis c virus [hcv]);
Description

Communicable Diseases Severe | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
6. any malignancy;
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
7. plasma triglycerides >400 mg/dl, plasma ldl-cholesterol > 250 mg/dl.
Description

Plasma triglyceride measurement | Plasma LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583329
UMLS CUI [2]
C1278149
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02380521

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent prior to any study specific procedures;
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
2. men and women with t2dm aged >18 years;
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
3. bmi >25 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 7.5-8.5 %;
boolean
C0474680 (UMLS CUI [1])
Metformin Dose U/day
Item
5. receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
1. pregnancy or willingness to become pregnant;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
2. moderate and severe liver dysfunction;
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
RENAL FAILURE MODERATE | Kidney Failure Severe
Item
3. moderate and severe renal failure;
boolean
C0748307 (UMLS CUI [1])
C0035078 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Cardiovascular event Major
Item
4. previous major cardiovascular event;
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Communicable Diseases Severe | HIV Infection | Hepatitis B | Hepatitis C
Item
5. severe infections at the discretion of the investigator (such as human immunodeficiency virus [hiv], hepatitis b virus [hbv] and hepatitis c virus [hcv]);
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Malignant Neoplasms
Item
6. any malignancy;
boolean
C0006826 (UMLS CUI [1])
Plasma triglyceride measurement | Plasma LDL cholesterol measurement
Item
7. plasma triglycerides >400 mg/dl, plasma ldl-cholesterol > 250 mg/dl.
boolean
C0583329 (UMLS CUI [1])
C1278149 (UMLS CUI [2])
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