Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

August 16, 2018 updated by: Rubina Heptulla, Albert Einstein College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Albert Einstein College of Medicine West Campus CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: 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.
Other Names:
  • Novolog
Active Comparator: 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.
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.
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
Time Frame: 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)
0-1500 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Medtronic

Investigators

  • Principal Investigator: Rubina A Heptulla, MD, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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