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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed loop with sensor and Insulin | Placebo Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed loop with sensor and Insulin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0-1500 min |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Rubina A Heptulla, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine West Campus CRC | The Bronx | New York | 10467 | United States |
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20 participants were screened. However only 18 participants were enrolled into the study. Of these 15 participants completed both study visits. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed Loop/Insulin First,Then Closed Loop/Insulin/Liraglutide | Participants underwent Closed Loop with Insulin first, as a continuous subcutaneous infusion for 2 days. Then they underwent the closed loop with Insulin and Liraglutide; insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the next 2 days. Each visit is 10 days apart. |
| FG001 | Closed Loop/Insulin/Liraglutide First,Then Closed Loop/Insulin | Participants underwent Closed Loop with Insulin and Liraglutide first, insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the first 2 days. Then they underwent the closed loop with Insulin alone, as a continuous subcutaneous infusion for the next 2 days. Each visit is 10 days apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention ( Upto 2 Days) |
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| Second Intervention (Upto 2 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either Closed Loop/Insulin subcutaneously or Closed Loop /Insulin/Liraglutide; 1.2 mg of Liraglutide subcutaneously as a single daily injection and insulin as a continuous subcutaneous infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | mg/dl | 0-1500 min |
|
12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Closed Loop/Insulin | Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rubina Heptulla | Children's Hospital at Montefiore | 718-920-7004 | rheptull@montefiore.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061267 | Insulin Aspart |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Closed loop with sensor, Insulin and Liraglutide | 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. |
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| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Closed Loop/Insulin/Liraglutide | Participants on Closed Loop with Insulin and Liraglutide, insulin as a continuous subcutaneous infusion and Liraglutide as a single daily subcutaneous injection of 1.2 mg for 2 days | 0 | 15 | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |