Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

NCT01755416 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of liraglutide combined with insulin to insulin alone in people with type 1 diabetes using a closed-loop insulin delivery system.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 18 people

Who can join Ages 18–40 · all sexes

Timeline Started 2013-01 · est. completion 2015-01

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01755416 ↗

Description as written by the study sponsor.

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.

Treatments tested

Closed loop with sensor and Insulin also known as Novolog Drug

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.
Closed loop with sensor, Insulin and Liraglutide also known as Victoza Drug

In this study visit the 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.

Main thing measured	Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
Sponsor	Albert Einstein College of Medicine
Conditions studied	Type 1 Diabetes
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01755416 ↗