CompletedPhase 2Results posted

Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

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

Lead sponsor

Albert Einstein College of Medicine

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c ≤8.5%

Primary endpoint

•Blood Glucose Measures

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01755416

Org study ID2012-503

Timeline

Milestones

Study first posted2012-12-24estimated

Last update posted2018-08-21actual

Results first posted2018-08-21actual

Study start2013-01 (month precision)

Primary completion2015-01actual (month precision)

Study completion2015-01actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

2 endpoints

Primary/registry result/low confidence

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

Time frame:0-1500 min

descriptive, improvement

Posted result

Group	Mean · mg/dl	95% CI
Closed Loop/Insulin	159.7	-
Closed Loop/Insulin/Liraglutide	144.6	-

Primary/protocol endpoint/low confidence

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

Time frame:0-1500 min

descriptive, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.