Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Closed loop with sensor and Insulin; Closed loop with sensor, Insulin and Liraglutide
Intervention description: Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.; In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Type 1 diabetes; closed loop; artificial pancreas; insulin; victoza; liraglutide

Summary:

      Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control
      system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic
      excursions than insulin mono-therapy.

      Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition
      of Liraglutide compared to insulin mono-therapy.

      Study Design: This is a randomized open labeled crossover design trial comparing adjuvant
      Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for
      insulin delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years and less than 40 years

          -  Have had diabetes for at least 1 year, and in good control (HbA1C < 8.5 %)

          -  Be on continuous subcutaneous insulin infusion using an insulin pump

          -  Menstruating women must have negative pregnancy test.

          -  Hemoglobin (Hb) > 12 g/dL

          -  Either is not treated with or has been on a stable treatment regimen with any of the
             following medications for a minimum of 3 months prior to Screening:

             a. Oral contraceptives (female subjects)b. Antihypertensive agents c. Lipid-lowering
             agents d. Thyroid replacement therapy e. Antidepressant agents

          -  For female subjects:a. Not breastfeeding b. Negative pregnancy test result (human
             chorionic gonadotropin, beta subunit [βhCG])at Screening c. If of childbearing
             potential, must practice and be willing to continue to practice appropriate birth
             control (defined as at least one method which results in a low failure rate, i.e.,
             less than 1% per year, when used consistently and correctly, such as implants,
             injectable's, hormonal contraceptives, some intrauterine contraceptive devices, sexual
             abstinence, tubal ligation or occlusion, or a vasectomized partner)during the entire
             duration of the study and must not be planning to conceive

          -  Should not have any alcohol or drug dependency as assessed by CRAFFT questionnaire.

        Exclusion Criteria:

          -  Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis,
             juvenile rheumatoid arthritis, etc., that directly, or as a result of treatment,
             directly or indirectly affect glucose homeostasis

          -  Hemoglobin less than 12 g/dl

          -  Positive pregnancy test in menstruating young women

          -  Evidence or history of chemical abuse

          -  HbA1c > 8.5 %

          -  Weight less than 50 Kg

          -  History of gastro paresis and on medications that alter gastric emptying

          -  History of Pancreatitis and impaired renal function

          -  Hypoglycemic unawareness

          -  History of sensitivity to 5-HT3 receptor antagonists

          -  History of QT prolongation or any known cardio-vascular disease

          -  Concomitant use of both Acetaminophen and vitamin C

          -  Patients on glucocorticoid therapy

          -  Known allergy to Liraglutide

          -  Personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary
             thyroid carcinoma or in patients with Multiple Endocrine Neoplasia (MEN) syndrome type
             2.