Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01755416

Run by

Albert Einstein College of Medicine

People needed

18

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2018-08-21

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Albert Einstein College of Medicine West Campus CRC — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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