Type 1 Diabetes Clinical Trial
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
NCT number | NCT01755416 |
Other study ID # | 2012-503 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2013 |
Est. completion date | January 2015 |
Verified date | August 2018 |
Source | Albert Einstein College of Medicine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 [ßhCG])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. |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine West Campus CRC | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine, Inc. | Medtronic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | 0-1500 min |
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