Clinical trial NCT01755416: Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
Official title: Phase 1 Study of Medtronic Closed Loop Device With ePID Algorithm and Enlite Sensors on Adjuvant Therapy With Insulin and Liraglutide to Minimize Post-prandial Hyperglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
closed loop
artificial pancreas
insulin
victoza
liraglutide
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2012-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
timeFrame: 0-1500 min
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine West Campus CRC
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Rubina A Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References: