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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01755416
First received: November 21, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Closed loop with enlite sensors, insulin, liraglutide
Device: Closed loop with enlite sensors, insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • To achieve better post-prandial glycemic measures while the subject is on the Medtronic closed loop device. [ Time Frame: 1470 minutes ] [ Designated as safety issue: Yes ]
    To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy while the study subjects are on the on the Medtronic Closed Loop Device with continuous subcutaneous insulin infusion based on subcutaneous glucose sensor values based on the ePID algorithm 2.0


Estimated Enrollment: 17
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enlite sensors, insulin, liraglutide
Closed loop with Enlite sensors, insulin, Liraglutide as a continuous subcutaneous infusion and a single subcutaneous injection of 1.2 mg before dinner on Day 1
Device: Closed loop with enlite sensors, insulin, 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 1.2mg of Liraglutide subcutaneoulsy before dinner on Day 1.
Device: Closed loop with enlite sensors, insulin
In this study visit the 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.
Active Comparator: Closed loop with enlite sensors, insulin
Subjects will be on the closed loop device with Novolog rapid acting insulin.
Device: Closed loop with enlite sensors, insulin
In this study visit the 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.

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755416

Contacts
Contact: jeniece Trast, RN, CDE 718-920-6191 jtrast@montefiore.org
Contact: Gina DiNapoli, PNP, CDE 718-920-5476 gdinapol@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine West Campus CRC Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Rubina A Heptulla, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Medtronic
Investigators
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01755416     History of Changes
Other Study ID Numbers: 2012-503
Study First Received: November 21, 2012
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Type 1 diabetes
closed loop
artificial pancreas
insulin
victoza
liraglutide

Additional relevant MeSH terms:
Insulin
Insulin, Globin Zinc
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014