Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

NCT ID: NCT01755416

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Closed loop with sensor and Insulin

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Closed loop with sensor, Insulin and Liraglutide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Closed loop with sensor, Insulin and Liraglutide

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 Type: DRUG

Other Intervention Names

Novolog; Victoza

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rubina Heptulla

Division Chief of Pediatric Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubina A Heptulla, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine West Campus CRC

The Bronx, New York, United States

Countries

United States

Other Identifiers

2012-503

Identifier Type: -

Identifier Source: org_study_id