Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
1. clinical diagnosis of type 2 diabetes with confirmed hba1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Age
Item
1. age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Medical contraindication Mealtime Insulin
Item
2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
boolean
C0011854 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Clinical state Requirement Hospital admission | Clinical state Requirement Inpatient treatment
Item
3. clinical state requiring inpatient admission/treatment;
boolean
C0457936 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0457936 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Medical contraindication Investigational New Drugs
Item
4. contraindication or strong cautions to any of the study medications:
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Creatinine measurement, serum | Gender
Item
1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Acidosis, Lactic
Item
2. history of lactic acidosis (per metformin label)
boolean
C0001125 (UMLS CUI [1])
Liver disease Advanced | Heart Disease Advanced
Item
3. advanced hepatic or cardiac disease (per metformin label)
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Age
Item
4. age >80 years (per metformin label)
boolean
C0001779 (UMLS CUI [1])
Alcohol consumption chronic | Drinks per week
Item
5. chronic alcohol use (>14 drinks/week)
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001967 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
Pancreatitis
Item
6. history of pancreatitis (per liraglutide label)
boolean
C0030305 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia
Item
7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
8. pregnancy and lactation (per liraglutide label)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Serious Interferes with Therapeutic procedure | Medical condition Unstable Interferes with Therapeutic procedure | Medical condition Serious Interferes with Outcome Measurement | Medical condition Unstable Interferes with Outcome Measurement
Item
5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2985619 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C2985619 (UMLS CUI [4,4])
Elective procedure Scheduled | Elective Surgical Procedures Scheduled
Item
6. any scheduled elective procedures/surgeries;
boolean
C0747973 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Communicable Diseases | Osteomyelitis
Item
7. active infections, including osteomyelitis;
boolean
C0009450 (UMLS CUI [1])
C0029443 (UMLS CUI [2])
Participation Unwilling | Protocol Compliance Unwilling
Item
8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6
boolean
C0679823 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
9. non english speaking.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])