Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Albert Einstein College of Medicine

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Closed loop with sensor, Insulin and Liraglutide; Drug: Closed loop with sensor and Insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01755416

2012-503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

Closed loop with sensor and Insulin

Placebo Comparator group

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.

Treatment:

Drug: Closed loop with sensor and Insulin

Closed loop with sensor, Insulin and Liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: Closed loop with sensor, Insulin and Liraglutide