Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, closed loop, artificial pancreas, insulin, victoza, liraglutide
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.
Interventions
DRUGClosed 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.
DRUGClosed 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.
Sponsors
Medtronic
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention ( Upto 2 Days) | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 26 Years STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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)
Time frame: 0-1500 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop/Insulin | Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone | 159.7 mg/dl | Standard Deviation 50.9 |
| Closed Loop/Insulin/Liraglutide | Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone | 144.6 mg/dl | Standard Deviation 36.3 |