Criteria Fulfill
Item
to enter the study subjects must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Insulin regime intense | Insulin detemir | Levemir | Insulin Aspart pre-meal | NovoLog
Item
1. have been on intensified insulin therapy with insulin detemir (levemir) and premeal insulin aspart (novolog®) for the previous 6 months.
boolean
C0557978 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0537270 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C1708521 (UMLS CUI [4,1])
C1546096 (UMLS CUI [4,2])
C0939412 (UMLS CUI [5])
Able to communicate Investigator | Legal competency Informed Consent
Item
2. be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0680554 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Gender Breast Feeding Absent | Postmenopausal state | Gender Contraceptive methods | Contraceptives, Oral | Hormone implant | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Pregnancy test negative
Item
3. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). female patients who have undergone a hysterectomy are eligible for participation in the study. female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0848131 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0015787 (UMLS CUI [10])
C0589114 (UMLS CUI [11])
C0278321 (UMLS CUI [12])
C0020699 (UMLS CUI [13])
C0079399 (UMLS CUI [14,1])
C0427780 (UMLS CUI [14,2])
Age
Item
4. age range of 18 to 70 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations chronic Dose Stable | Double-Blind Method
Item
5. patients must have been on a stable dose of allowed chronic medications for 6 months prior to entering the double-blind treatment period.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0013072 (UMLS CUI [2])
Laboratory Results
Item
6. all participants must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1])
Hemoglobin measurement | Gender | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
hemoglobin ≥12 g/dl in males or ≥11 g/dl in females serum creatinine ≤1.5 mg/dl ast (sgot) and alt (sgpt) ≤2.5 times upper limit of normal alkaline phosphatase ≤2.5 times upper limit of normal
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
Criteria Fulfill
Item
patients will be excluded if any of the following criteria are present:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement | Insulin regime Poor compliance
Item
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl; poor compliance with insulin therapy.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0557978 (UMLS CUI [4,1])
C0032646 (UMLS CUI [4,2])
Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable
Item
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 6 months prior to study entry.
boolean
C0038766 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Thiazide Diuretics | Furosemide | Adrenergic beta-Antagonists | Pharmaceutical Preparations chronic Adverse effects Glucose tolerance | Exception Dose Stable | Estrogens Dose Stable allowed | Hormone replacement therapy allowed | Glucocorticoids, Systemic
Item
3. patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. patients taking systemic glucocorticoids will be excluded.
boolean
C0012802 (UMLS CUI [1])
C0016860 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0879626 (UMLS CUI [4,3])
C0178665 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0014939 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
C0282402 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C3540777 (UMLS CUI [8])
Alcohol abuse
Item
4. past (within 1 year) or current history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Heart Disease New York Heart Association Classification | Peripheral Vascular Disease | Claudication | Lung diseases | Dyspnea on exertion | Abnormal breath sounds Auscultation | Kidney Failure, Chronic | Creatinine measurement, serum
Item
5. patients will be excluded if there is a history of clinically significant heart disease (new york heart classification greater than grade ii), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C1456822 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0231807 (UMLS CUI [5])
C0231856 (UMLS CUI [6,1])
C0004339 (UMLS CUI [6,2])
C0022661 (UMLS CUI [7])
C0201976 (UMLS CUI [8])