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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755416
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Closed loop with sensor and Insulin Drug: Closed loop with sensor, Insulin and Liraglutide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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 Name: 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 Name: Victoza


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755416


Locations
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United States, New York
Albert Einstein College of Medicine West Campus CRC
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
Medtronic
Investigators
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Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01755416    
Other Study ID Numbers: 2012-503
First Posted: December 24, 2012    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: August 21, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Rubina Heptulla, Albert Einstein College of Medicine:
Type 1 diabetes
closed loop
artificial pancreas
 insulin
victoza
liraglutide
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
 Insulin, Globin Zinc
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists