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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Closed loop with sensor and Insulin
Closed loop with sensor, Insulin and Liraglutide
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, closed loop, artificial pancreas, insulin, victoza, liraglutide

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Albert Einstein College of Medicine West Campus CRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Closed loop with sensor and Insulin

Closed loop with sensor, Insulin and Liraglutide

Arm 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.

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.

Outcomes

Primary Outcome Measures

Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
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)

Secondary Outcome Measures

Full Information

First Posted
November 21, 2012
Last Updated
August 16, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01755416
Brief Title
Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, closed loop, artificial pancreas, insulin, victoza, liraglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed loop with sensor and Insulin
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Closed loop with sensor, Insulin and Liraglutide
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Closed loop with sensor and Insulin
Other Intervention Name(s)
Novolog
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Closed loop with sensor, Insulin and Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
Description
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)
Time Frame
0-1500 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubina A Heptulla, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine West Campus CRC
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

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