Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

NCTNCT01755416Other id2012-503

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 18 participants (actual)
Sponsor: Albert Einstein College of Medicine · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2013
Primary completion: Jan 2015
Completion: Jan 2015
First posted: 24 Dec 2012 (estimated)
Last update posted: 21 Aug 2018
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016

Ph 2
Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
NCT01755416
Jan 2013 to Jan 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Closed loop with sensor and InsulinDrug
Closed loop with sensor, Insulin and LiraglutideDrug

Arms2

Placebo comparator
Closed 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.
Active comparator
Closed loop with sensor, Insulin and Liraglutide
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0-1500 min

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

Group	Value (mg/dl)	Spread
Closed Loop/Insulin	159.7	50.9
Closed Loop/Insulin/Liraglutide	144.6	36.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Closed Loop/InsulinParticipants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days.	0 / 15	0 / 15	0 / 15
Closed Loop/Insulin/LiraglutideParticipants on Closed Loop with Insulin and Liraglutide, insulin as a continuous subcutaneous infusion and Liraglutide as a single daily subcutaneous injection of 1.2 mg for 2 days	0 / 15	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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