ID

1. type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at

boolean

C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0454291 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
C1299007 (UMLS CUI [6])

Combined Modality Therapy Low dose Stable

Item

≤ 50% maximal dose (see appendix). dosing is stable for 8 weeks prior to randomization.

boolean

C0009429 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])

Plasma fasting glucose measurement | Glycosylated hemoglobin A

Item

2. fpg ≤ 225 mg/dl and hba1c>7% and ≤9.5% at screening

boolean

C0583513 (UMLS CUI [1])
C0019018 (UMLS CUI [2])

Age

Item

3. age ≥18 and <75

boolean

C0001779 (UMLS CUI [1])

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm

Item

4. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm)

boolean

C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0042241 (UMLS CUI [4])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Item

1. type 1 diabetes and/or history of ketoacidosis determined by medical history

boolean

C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])

Diabetic Neuropathy Severe | Autonomic neuropathy | Gastroparesis | Leg Ulcer | Amputation of lower limb

Item

2. history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation

boolean

C0011882 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
C0023223 (UMLS CUI [4])
C0337308 (UMLS CUI [5])

Insulin Long-term

Item

3. history of long-term therapy with insulin (>30 days) within the last year

boolean

C0021641 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])

Item

4. therapy with rosiglitazone (avandia) or pioglitazone (actos), or extendin-4 (byetta), alone or in combination in the previous 6 months

boolean

C0289313 (UMLS CUI [1])
C0875967 (UMLS CUI [2])
C0071097 (UMLS CUI [3])
C0875954 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1636686 (UMLS CUI [6])
C0009429 (UMLS CUI [7])

Pregnancy | Breast Feeding

Item

5. pregnancy or lactation

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Adrenal Cortex Hormones | Adrenal Cortex Hormones Oral Recurrent

Item

6. patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)

boolean

C0001617 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])

Item

7. use of weight loss drugs [e.g., xenical (orlistat), meridia (sibutramine), acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months

boolean

C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0635898 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C0031495 (UMLS CUI [6])
C0013231 (UMLS CUI [7,1])
C2348205 (UMLS CUI [7,2])
C1563041 (UMLS CUI [8])

Operative Surgical Procedures

Item

8. surgery within 30 days prior to screening

boolean

C0543467 (UMLS CUI [1])

Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate | Chronic Kidney Disease Stage MDRD

Item

9. serum creatinine >1.4 for women and >1.5 for men or egfr <60 [possible chronic kidney disease stage 3 or greater calculated using the modification of diet in renal disease (mdrd) equation.

boolean

C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
C1561643 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])

Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic

Item

10. history of chronic liver disease including hepatitis b or c

boolean

C0341439 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])

Peptic Ulcer | Gastritis Endoscopy

Item

11. history of peptic ulcer or endoscopy demonstrated gastritis

boolean

C0030920 (UMLS CUI [1])
C0017152 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])

Acquired Immunodeficiency Syndrome | HIV Infection

Item

12. history of acquired immune deficiency syndrome or human immunodeficiency virus (hiv)

boolean

C0001175 (UMLS CUI [1])
C0019693 (UMLS CUI [2])

Malignant Neoplasms | Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin

Item

13. history of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma

boolean

C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4])

Cardiac Status New York Heart Association Classification | Hospitalization Congestive heart failure

Item

14. new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure

boolean

C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Revascularization

Item

15. history of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months

boolean

C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0581603 (UMLS CUI [5])

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Item

16. uncontrolled hypertension (defined as systolic blood pressure >150 mmhg or diastolic blood pressure >95 mmhg on three or more assessments on more than one day)

boolean

C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])

Substance Use Disorders | Alcohol consumption U/week | Beer U/week | Wine U/week | Cocktail Containing Alcohol U/week

Item

17. history of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)

boolean

C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
C0004922 (UMLS CUI [3,1])
C0560588 (UMLS CUI [3,2])
C0043188 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0678420 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0001962 (UMLS CUI [5,3])
C0560588 (UMLS CUI [5,4])

Hemoglobin measurement | Gender

Item

18. hemoglobin <12 g/dl (males), <10 g/dl (females) at screening

boolean

C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])

Platelet Count measurement

Item

19. platelets <100,000 cu mm at screening.

boolean

C0032181 (UMLS CUI [1])

Aspartate aminotransferase increased | Alanine aminotransferase increased

Item

20. ast (sgot) >2.50 x uln or alt (sgpt) >2.50 x uln at screening

boolean

C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])

Elevated total bilirubin

Item

21. total bilirubin >1.50 x uln at screening

boolean

C0741494 (UMLS CUI [1])

Triglycerides measurement

Item

22. triglycerides (tg) >500 mg/dl at screening

boolean

C0202236 (UMLS CUI [1])

Mental function Poor | Reason for Protocol Compliance Limited

Item

23. poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study

boolean

C0563143 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])

Aspirin allergy

Item

24. previous allergy to aspirin

boolean

C0004058 (UMLS CUI [1])

Non-Steroidal Anti-Inflammatory Agents chronic

Item

25. chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months

boolean

C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])

Warfarin | Coumadin | clopidogrel | Plavix | Anticoagulants

Item

26. use of warfarin (coumadin), clopidogrel (plavix) or other anticoagulants

boolean

C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0633084 (UMLS CUI [4])
C0003280 (UMLS CUI [5])

Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents

Item

27. use of probenecid (benemid, probalan), sulfinpyrazone (anturane) or other uricosuric agents

boolean

C0033209 (UMLS CUI [1])
C0591159 (UMLS CUI [2])
C0038742 (UMLS CUI [3])
C0591099 (UMLS CUI [4])
C0041983 (UMLS CUI [5])

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Eligibility Type 2 Diabetes NCT00392678