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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01755416•Albert Einstein College of Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Albert Einstein College of Medicine West Campus CRC

The Bronx, New York, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

August 21, 2018

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Closed loop with sensor and Insulin

DRUG

Closed loop with sensor, Insulin and Liraglutide

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery