Age
Item
1. male or female, age 18 to 70
boolean
C0001779 (UMLS CUI [1])
Gender Breast Feeding Absent | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
2. females are non-lactating and using adequate contraception, in the opinion of the principal investigator and negative serum pregnancy test if of child bearing potential (intact uterus and pre-menopausal)
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Non-Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus Untreated | Diet therapy Exercise Only | Pharmacotherapy
Item
3. diagnosis of type 2 diabetes mellitus (dm) for at least 6 months. type 2 diabetes may be untreated or may be treated with diet and exercise only and/or pharmacologic therapy as in inclusion criterion 4
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0012159 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0013216 (UMLS CUI [4])
Pharmacotherapy Stable Non-Insulin-Dependent Diabetes Mellitus | Glucophage Less Than Dose Maximum | Metformin Less Than Dose Maximum | Glucophage XR Less Than Dose Maximum
Item
4. pharmacologic treatment for type 2 dm may include the following and must be stable for > 3 months glucophage (metformin) (< maximum dose of 2550 mg) or glucophage xr (< maximum dose of 2000 mg)
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0591573 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0806909 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0439092 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0806909 (UMLS CUI [3,4])
C0939699 (UMLS CUI [4,1])
C0439092 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0806909 (UMLS CUI [4,4])
Glycosylated hemoglobin A
Item
5. hba1c level of 6.5 to 10.9%
boolean
C0019018 (UMLS CUI [1])
fasting C-peptide level
Item
6. fasting c-peptide level of greater than or equal to 0.8 nmol/l (2.4 ng/ml)
boolean
C2208720 (UMLS CUI [1])
Cosyntropin test | Cortisol level
Item
7. acth stimulation test results with any cortisol level (baseline, 30 or 60 minutes) of >18 µg/dl
boolean
C0201971 (UMLS CUI [1])
C0428396 (UMLS CUI [2])
Thyroid stimulating hormone normal
Item
8. normal thyroid stimulating hormone
boolean
C0858305 (UMLS CUI [1])
Ischemia Absent 12 lead ECG | Abnormality Absent 12 lead ECG
Item
9.12-lead electrocardiogram (ecg) shows no acute ischemia or clinically significant abnormality
boolean
C0022116 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430456 (UMLS CUI [2,3])
Body mass index
Item
10.bmi of 26 to 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Antihypertensive therapy Stable Hypertensive disease
Item
11.subjects with a history of hypertension may be on a stable anti-hypertensive regimen (except those drugs stated under exclusion criterion 7) for > 2 months
boolean
C0585941 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
Informed Consent
Item
12.ability to comprehend and a willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Atherosclerosis | Myocardial Infarction | Angina Pectoris | Cerebrovascular accident | Peripheral Vascular Diseases | Congestive heart failure Secondary to Ischemic cardiomyopathy | Antilipemic agent To be stopped
Item
1. history of any atherosclerotic disorder (myocardial infarction, angina, cerebrovascular accident, peripheral vascular disease or congestive heart failure secondary to ischemic myocardial injury) that would, in the estimation of the investigator, make it unsafe to stop all lipid lowering drugs during the course of the study
boolean
C0004153 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
C0349782 (UMLS CUI [6,3])
C0086440 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
Ketoconazole allergy | Idiosyncratic reaction Ketoconazole | Hypersensitivity Imidazole Compound | Idiosyncratic reaction Imidazole Compound
Item
2. known hypersensitivity or idiosyncratic reaction related to ketoconazole or other imidazole compounds
boolean
C0571275 (UMLS CUI [1])
C0745213 (UMLS CUI [2,1])
C0022625 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0020923 (UMLS CUI [3,2])
C1706082 (UMLS CUI [3,3])
C0745213 (UMLS CUI [4,1])
C0020923 (UMLS CUI [4,2])
C1706082 (UMLS CUI [4,3])
Malignant Neoplasms | Basal cell carcinoma
Item
3. history of malignancy (except basal cell carcinoma) within the 3 years before the initial dose of the study medication
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Alcohol intake above recommended sensible limits | Drug abuse
Item
4. excessive alcohol intake or drug abuse using the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv), criteria
boolean
C0560219 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Medical condition Limiting Activities of Daily Living | Proliferative diabetic retinopathy | Neuropathy Symptoms
Item
5. any other clinically significant medical condition, as determined by the investigator. these clinically significant medical conditions include proliferative diabetic retinopathy and neuropathic symptoms that limit activities of daily living
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
C0154830 (UMLS CUI [2])
C0442874 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
6. participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Antacids | Anti-Ulcer Agent | Weight-Loss Agents | Oral hypoglycemic | Hypoglycemic Agents Injection | Metformin | Insulin | Steroids | Cyclosporine | Tacrolimus | Midazolam | Digoxin | Coumarins | Phenytoin | Rifampin | Loratadine | HIV Protease Inhibitors | Spironolactone | Thiazide Diuretics | Calcium Channel Blockers | Erythromycin | Antilipemic agent To be stopped
Item
7. concomitant therapy with the following: any antacid or ulcer medication, weight loss medications, oral or injected hypoglycemics (metformin is allowed) or insulin, steroids, cyclosporine, tacrolimus, midazolam, digoxin, coumarin derivatives, phenytoin, rifampin, loratadine, hiv protease inhibitors, spironolactone, thiazide diuretics, calcium channel blockers and erythromycin. subjects taking lipid lowering medications may be enrolled if investigator determines that subject does not have any conditions that preclude this cessation and subject is willing to stop such medications 21 days prior to study visit 1 through study visit 3 (day 16)
boolean
C0003138 (UMLS CUI [1])
C0003216 (UMLS CUI [2])
C0376606 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6])
C0021641 (UMLS CUI [7])
C0038317 (UMLS CUI [8])
C0010592 (UMLS CUI [9])
C0085149 (UMLS CUI [10])
C0026056 (UMLS CUI [11])
C0012265 (UMLS CUI [12])
C0010207 (UMLS CUI [13])
C0031507 (UMLS CUI [14])
C0035608 (UMLS CUI [15])
C0065180 (UMLS CUI [16])
C0162714 (UMLS CUI [17])
C0037982 (UMLS CUI [18])
C0012802 (UMLS CUI [19])
C0006684 (UMLS CUI [20])
C0014806 (UMLS CUI [21])
C0086440 (UMLS CUI [22,1])
C1272691 (UMLS CUI [22,2])
HIV Infection
Item
8. history of hiv
boolean
C0019693 (UMLS CUI [1])
Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive
Item
9. positive hepatitis b (hbsag) or positive hepatitis c (hepatitis c antibody) test during screening
boolean
C0856706 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
White Blood Cell Count procedure
Item
10. wbc count <4000/µl or >14,000/µl
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
11. hemoglobin <12.0 gm/dl in females and <14.0 gm/dl in males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
12. any single hepatic enzyme (alt, ast, ap and total bilirubin) is greater than the upper limit of the normal reference range used by the central laboratory
boolean
C0235996 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C0741494 (UMLS CUI [5])
Serum creatinine raised
Item
13. creatinine > 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Hypersensitivity Cosyntropin | Hypersensitivity ACTH | Hypersensitivity ACTH Component | Mannitol allergy | Hypersensitivity Sodium Chloride
Item
14. known hypersensitivity to cosyntropin (acth) or any component of the formulation (mannitol or sodium chloride)
boolean
C0020517 (UMLS CUI [1,1])
C0010192 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001655 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0001655 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0037494 (UMLS CUI [5,2])