Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Glycaemia control Improve
Item
type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C3267174 (UMLS CUI [4,1])
C0184511 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c>7% and ≤10.5% at randomization.
boolean
C0474680 (UMLS CUI [1])
Age
Item
men and women of 18-75 years of age.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test
Item
women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. a urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. if positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430064 (UMLS CUI [3,2])
Treatment Stable Blood Pressure | Antihypertensive therapy unchanged | Treatment Absent
Item
blood pressure≥ 130/80 mm hg and ≤160/100mmhg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. no change in treatment for bp over 8 weeks of the study will be allowed.
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Comprehension Study Protocol | Informed Consent
Item
patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
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 Severe | Gastroparesis | Limb Ulceration | Amputation of limb
Item
2. history of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
boolean
C0011882 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0152020 (UMLS CUI [3])
C0015385 (UMLS CUI [4,1])
C3887532 (UMLS CUI [4,2])
C0002689 (UMLS CUI [5])
Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Analogue | GLP-1 Receptor Agonist
Item
3. therapy with dpp-4 inhibitor, or glp -1 analog or receptor agonist in the past 6 months.
boolean
C3537225 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C2917359 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
4. pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Adrenal Cortex Hormones | Steroid therapy Continuous Recurrent
Item
5. patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (>2 weeks).
boolean
C0001617 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Weight-Loss Agents | Weight loss Percentage Timespan
Item
6. use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
boolean
C0376606 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Operative Surgical Procedures | Illness Serious | Chronic disease | Operative Surgical Procedures Anticipated
Item
7. surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.
boolean
C0543467 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C3840775 (UMLS CUI [4,2])
Creatinine measurement, serum | Gender | Triglycerides measurement | Pancreatitis | Substance Use Disorders | Mental function Poor | Difficulty with Protocol Compliance
Item
8. serum creatinine >1.4mg/dl (women)/>1.5mg/dl (men). 9. serum triglyceride level >500 mg/dl. 10. history of pancreatitis. 11. history of drug or alcohol abuse. 12. poor mental function or any reason to expect patient difficulty in complying with study requirements.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C0563143 (UMLS CUI [6,1])
C0542537 (UMLS CUI [6,2])
C0332218 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
Medical contraindication Liraglutide | History of Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Hypersensitivity Liraglutide | Hypersensitivity Suspected Liraglutide | Secondary hypertension
Item
13. contraindications to liraglutide: personal or family history of medullary thyroid cancer or men-2 syndrome 14. known or suspected allergy to liraglutide. 15. diagnosed secondary hypertension.
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0238462 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
C0027662 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1456408 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1456408 (UMLS CUI [6,3])
C0155616 (UMLS CUI [7])