ID

42361

Description

A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01794143

Link

https://clinicaltrials.gov/show/NCT01794143

Keywords

  1. 6/23/21 6/23/21 -
Copyright Holder

GRADE Study Group

Uploaded on

June 23, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Glycemia-Lowering Medication NCT01794143

Eligibility Type 2 Diabetes Glycemia-Lowering Medication NCT01794143

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for american indians)
Description

Age at type 2 diabetes diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1828181
UMLS CUI [1,2]
C0011860
2. duration of diagnosed diabetes < 10 years
Description

Type 2 diabetes duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
3. hba1c criteria (at final run-in visit, ~2 weeks prior to randomization): 6.8-8.5%
Description

HbA1c before randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0034656
4. taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in
Description

Daily dose of metformin before randomization duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0034656
UMLS CUI [1,5]
C0449238
5. willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose
Description

Willing to administer subcutaneous injections daily | willing pharmaceutical preparations DM additional post randomization | willing to initiate or increase insulin if indicated | willing to perform self-monitoring of blood glucose

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0036589
UMLS CUI [1,3]
C0021499
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0011849
UMLS CUI [2,4]
C1524062
UMLS CUI [2,5]
C0687676
UMLS CUI [2,6]
C0034656
UMLS CUI [3,1]
C0600109
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C1704686
UMLS CUI [3,4]
C3146298
UMLS CUI [4,1]
C0600109
UMLS CUI [4,2]
C0021641
UMLS CUI [4,3]
C0442805
UMLS CUI [4,4]
C3146298
UMLS CUI [5,1]
C0600109
UMLS CUI [5,2]
C0005803
6. fluent in either english or spanish
Description

Fluent in English | fluent in Spanish

Data type

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0037750
7. a negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
Description

Negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
8. provision of signed and dated informed consent prior to any study procedures
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis)
Description

T1D suspected diagnosis | polyuria polydipsia decreased weight lacking treatment response to metformin | monogenic diabetes | diabetes secondary to pancreatic surgery | diabetes secondary to pancreatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0332147
UMLS CUI [2,1]
C0032617
UMLS CUI [2,2]
C0085602
UMLS CUI [2,3]
C1262477
UMLS CUI [2,4]
C0332268
UMLS CUI [2,5]
C0521982
UMLS CUI [2,6]
C0025598
UMLS CUI [3]
C3888631
UMLS CUI [4,1]
C0011847
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0543467
UMLS CUI [4,4]
C0030274
UMLS CUI [5,1]
C0011847
UMLS CUI [5,2]
C0175668
UMLS CUI [5,3]
C0030305
2. current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin
Description

Current or recent hypoglycemic treatment | exception metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
3. more than 10 years of treatment with metformin at time of randomization screening
Description

Metformin duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0449238
4. history of intolerance or allergy or other contraindications to any of the proposed study medications
Description

Intolerance to study medication | hypersensitivity to study medication | other contraindications to study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C3854006
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3854006
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C3854006
5. resides in the same household with another grade study participant
Description

Participant cohabitates with another study participant

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0221179
UMLS CUI [1,3]
C1997894
UMLS CUI [1,4]
C0205394
6. current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome
Description

Glucose-lowering agents disease other | polycystic ovary syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C0032460
7. symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician
Description

Symptomatic hyperglycemia requiring immediate therapy, in the judgment of the physician

Data type

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C0020456
UMLS CUI [1,4]
C0231220
UMLS CUI [1,5]
C1514873
UMLS CUI [1,6]
C0087111
UMLS CUI [1,7]
C0205253
8. a life-threatening event within 30 days prior to screening or currently planned major surgery
Description

Recent life-threatening event | planned major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1301732
9. any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty.
Description

Recent major cardiovascular event | history of myocardial infarction | stroke | vascular procedure | coronary artery or peripheral bypass grafting | peripheral stent placements | coronary stent placements | angioplasty

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332185
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0042381
UMLS CUI [5]
C0010055
UMLS CUI [6]
C3495795
UMLS CUI [7]
C0522776
UMLS CUI [8]
C0948884
UMLS CUI [9]
C0162577
10. plans for pregnancy during the course of the study for women of child-bearing potential
Description

Pregnancy intention during clinical trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0162425
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
11. history of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year)
Description

(Planned) bariatric surgery | banding procedures | surgical gastric bypass | surgical intestinal bypass

Data type

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C1456587
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0524722
UMLS CUI [3,2]
C1719687
UMLS CUI [4,1]
C0524722
UMLS CUI [4,2]
C0017125
UMLS CUI [5,1]
C0524722
UMLS CUI [5,2]
C0022375
12. history of congestive heart failure (nyha 3 or greater)
Description

History of congestive heart failure | NYHA class

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C1275491
13. history of pancreatitis
Description

History of pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
14. history of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
Description

Malign neoplasms requiring prior therapy | except skin carcinoma nonmelanomatous

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1518408
15. personal or family history of men-2 or family history of medullary thyroid cancer
Description

Personal or family history of multiple endocrine neoplasia | family history of medullary thyroid cancer

Data type

boolean

Alias
UMLS CUI [1]
C0027662
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0241889
UMLS CUI [3,1]
C0238462
UMLS CUI [3,2]
C0241889
16. serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men or end stage renal disease requiring renal replacement therapy
Description

Serum creatinine | end stage renal disease requiring renal replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0206074
17. history of severe liver disease or acute hepatitis or alt > 3 times upper limit of normal
Description

Severe liver disease | acute hepatitis | elevated ALT

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0267797
UMLS CUI [3]
C0201836
18. current alcoholism or excessive alcohol intake
Description

Alcoholism | excessive alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0442802
19. previous organ transplant
Description

Previous organ transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205156
20. treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed)
Description

Treatment with oral or systemic glucocorticoids other than short-term treatment | disease likely to require glucocorticoid therapy | inhaled steroids allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017710
UMLS CUI [2,3]
C1527415
UMLS CUI [2,4]
C0443303
UMLS CUI [3]
C3540777
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3540777
UMLS CUI [4,3]
C0443303
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0750492
UMLS CUI [5,4]
C0744425
UMLS CUI [6]
C2065041
21. treatment with atypical antipsychotics
Description

Atypical antipsychotics

Data type

boolean

Alias
UMLS CUI [1]
C1276996
22. history of hemolytic anemia, chronic transfusion requirement, or other condition rendering hba1c results unreliable as indicator of chronic glucose levels, or hematocrit <35 for males and <33 for females
Description

Hemolytic anemia | chronic transfusion requirement | other condition hba1c results unreliable | hematocrit level

Data type

boolean

Alias
UMLS CUI [1]
C0002878
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1879316
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C0474680
UMLS CUI [3,4]
C0749770
UMLS CUI [4]
C0518014
23. clinically or medically unstable with expected survival <1 year
Description

Unstable clinical status | unstable medical status | life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0443343
UMLS CUI [2,2]
C0205476
UMLS CUI [3]
C0023671
24. unwillingness to permit sites to contact the pcp to communicate information about the study and the participant's data
Description

Unwilling to permit contact with PCP

Data type

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0521104
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C0033131
25. no non-study pcp or inability to identify such a pcp (who will provide non-study care) by the time of final run-in
Description

No primary care physician | inability to identify primary care physician

Data type

boolean

Alias
UMLS CUI [1,1]
C0033131
UMLS CUI [1,2]
C1706613
UMLS CUI [2,1]
C0033131
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C1299582
26. participation in another interventional clinical trial
Description

Participation in another interventional clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3274035
27. previous randomization in the grade study
Description

Previous randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0205156
28. in the opinion of the principal investigator (pi), any other factor, including language barrier, likely to limit compliance with the protocol
Description

Factors limiting protocol compliance judgement principle investigator | language barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C1521895
UMLS CUI [2]
C0237167

Similar models

Eligibility Type 2 Diabetes Glycemia-Lowering Medication NCT01794143

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age at type 2 diabetes diagnosis
Item
1. men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for american indians)
boolean
C1828181 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Type 2 diabetes duration
Item
2. duration of diagnosed diabetes < 10 years
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
HbA1c before randomization
Item
3. hba1c criteria (at final run-in visit, ~2 weeks prior to randomization): 6.8-8.5%
boolean
C0474680 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Daily dose of metformin before randomization duration
Item
4. taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
C0449238 (UMLS CUI [1,5])
Willing to administer subcutaneous injections daily | willing pharmaceutical preparations DM additional post randomization | willing to initiate or increase insulin if indicated | willing to perform self-monitoring of blood glucose
Item
5. willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose
boolean
C0600109 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0021499 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0600109 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
C1524062 (UMLS CUI [2,4])
C0687676 (UMLS CUI [2,5])
C0034656 (UMLS CUI [2,6])
C0600109 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1704686 (UMLS CUI [3,3])
C3146298 (UMLS CUI [3,4])
C0600109 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C3146298 (UMLS CUI [4,4])
C0600109 (UMLS CUI [5,1])
C0005803 (UMLS CUI [5,2])
Fluent in English | fluent in Spanish
Item
6. fluent in either english or spanish
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Negative pregnancy test
Item
7. a negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
boolean
C0427780 (UMLS CUI [1])
Informed consent
Item
8. provision of signed and dated informed consent prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
T1D suspected diagnosis | polyuria polydipsia decreased weight lacking treatment response to metformin | monogenic diabetes | diabetes secondary to pancreatic surgery | diabetes secondary to pancreatitis
Item
1. suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis)
boolean
C0011854 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2,1])
C0085602 (UMLS CUI [2,2])
C1262477 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
C0521982 (UMLS CUI [2,5])
C0025598 (UMLS CUI [2,6])
C3888631 (UMLS CUI [3])
C0011847 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0030274 (UMLS CUI [4,4])
C0011847 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
Current or recent hypoglycemic treatment | exception metformin
Item
2. current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin
boolean
C0020616 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Metformin duration
Item
3. more than 10 years of treatment with metformin at time of randomization screening
boolean
C0025598 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Intolerance to study medication | hypersensitivity to study medication | other contraindications to study medication
Item
4. history of intolerance or allergy or other contraindications to any of the proposed study medications
boolean
C1744706 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3854006 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C3854006 (UMLS CUI [3,3])
Participant cohabitates with another study participant
Item
5. resides in the same household with another grade study participant
boolean
C2348568 (UMLS CUI [1,1])
C0221179 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Glucose-lowering agents disease other | polycystic ovary syndrome
Item
6. current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome
boolean
C0020616 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0032460 (UMLS CUI [2])
Symptomatic hyperglycemia requiring immediate therapy, in the judgment of the physician
Item
7. symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0020456 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C0087111 (UMLS CUI [1,6])
C0205253 (UMLS CUI [1,7])
Recent life-threatening event | planned major surgery
Item
8. a life-threatening event within 30 days prior to screening or currently planned major surgery
boolean
C1517874 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Recent major cardiovascular event | history of myocardial infarction | stroke | vascular procedure | coronary artery or peripheral bypass grafting | peripheral stent placements | coronary stent placements | angioplasty
Item
9. any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty.
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0042381 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C3495795 (UMLS CUI [6])
C0522776 (UMLS CUI [7])
C0948884 (UMLS CUI [8])
C0162577 (UMLS CUI [9])
Pregnancy intention during clinical trial period
Item
10. plans for pregnancy during the course of the study for women of child-bearing potential
boolean
C0032961 (UMLS CUI [1,1])
C0162425 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
(Planned) bariatric surgery | banding procedures | surgical gastric bypass | surgical intestinal bypass
Item
11. history of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year)
boolean
C1456587 (UMLS CUI [1])
C1456587 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0524722 (UMLS CUI [3,1])
C1719687 (UMLS CUI [3,2])
C0524722 (UMLS CUI [4,1])
C0017125 (UMLS CUI [4,2])
C0524722 (UMLS CUI [5,1])
C0022375 (UMLS CUI [5,2])
History of congestive heart failure | NYHA class
Item
12. history of congestive heart failure (nyha 3 or greater)
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
History of pancreatitis
Item
13. history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Malign neoplasms requiring prior therapy | except skin carcinoma nonmelanomatous
Item
14. history of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1518408 (UMLS CUI [2,3])
Personal or family history of multiple endocrine neoplasia | family history of medullary thyroid cancer
Item
15. personal or family history of men-2 or family history of medullary thyroid cancer
boolean
C0027662 (UMLS CUI [1])
C0027662 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0238462 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Serum creatinine | end stage renal disease requiring renal replacement therapy
Item
16. serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men or end stage renal disease requiring renal replacement therapy
boolean
C0201976 (UMLS CUI [1])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0206074 (UMLS CUI [2,3])
Severe liver disease | acute hepatitis | elevated ALT
Item
17. history of severe liver disease or acute hepatitis or alt > 3 times upper limit of normal
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alcoholism | excessive alcohol consumption
Item
18. current alcoholism or excessive alcohol intake
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
Previous organ transplant
Item
19. previous organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Treatment with oral or systemic glucocorticoids other than short-term treatment | disease likely to require glucocorticoid therapy | inhaled steroids allowed
Item
20. treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed)
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
C3540777 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3540777 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0750492 (UMLS CUI [5,3])
C0744425 (UMLS CUI [5,4])
C2065041 (UMLS CUI [6])
Atypical antipsychotics
Item
21. treatment with atypical antipsychotics
boolean
C1276996 (UMLS CUI [1])
Hemolytic anemia | chronic transfusion requirement | other condition hba1c results unreliable | hematocrit level
Item
22. history of hemolytic anemia, chronic transfusion requirement, or other condition rendering hba1c results unreliable as indicator of chronic glucose levels, or hematocrit <35 for males and <33 for females
boolean
C0002878 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1879316 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0474680 (UMLS CUI [3,3])
C0749770 (UMLS CUI [3,4])
C0518014 (UMLS CUI [4])
Unstable clinical status | unstable medical status | life expectancy
Item
23. clinically or medically unstable with expected survival <1 year
boolean
C0443343 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443343 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Unwilling to permit contact with PCP
Item
24. unwillingness to permit sites to contact the pcp to communicate information about the study and the participant's data
boolean
C0558080 (UMLS CUI [1,1])
C0521104 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0033131 (UMLS CUI [1,4])
No primary care physician | inability to identify primary care physician
Item
25. no non-study pcp or inability to identify such a pcp (who will provide non-study care) by the time of final run-in
boolean
C0033131 (UMLS CUI [1,1])
C1706613 (UMLS CUI [1,2])
C0033131 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Participation in another interventional clinical trial
Item
26. participation in another interventional clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C3274035 (UMLS CUI [1,2])
Previous randomization
Item
27. previous randomization in the grade study
boolean
C0034656 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Factors limiting protocol compliance judgement principle investigator | language barrier
Item
28. in the opinion of the principal investigator (pi), any other factor, including language barrier, likely to limit compliance with the protocol
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C1521895 (UMLS CUI [1,5])
C0237167 (UMLS CUI [2])

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