Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Phase 2

Completed

Interventions: Drug: Closed loop with sensor and Insulin
Drug: Closed loop with sensor, Insulin and Liraglutide

Brief 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.

Detailed Description: After the screening visit, subjects will be randomized to come for two overnight visits. Study A- the subjects will be on the closed loop device with Novolog rapid acting insulin. In Study B- in addition to insulin the subjects will take a one time sub cutaneous injection of 1.2 mg of Victoza before dinner on Day 1. Both visits will last for approximately 30 hours and the subjects will be managed by the closed loop device for approximately 25 hours.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Closed loop with sensor and Insulin	Closed loop with sensor and Insulin	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.
Closed loop with sensor, Insulin and Liraglutide	Closed loop with sensor, Insulin and Liraglutide	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.

Primary Outcome Measures

Name	Time	Method
Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone	0-1500 min	Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)

Secondary Outcome Measures

Name	Time	Method

Locations (1): Albert Einstein College of Medicine West Campus CRC
🇺🇸
Bronx, New York, United States
Albert Einstein College of Medicine West Campus CRC
🇺🇸Bronx, New York, United States