Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT01755416
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Closed loop with sensor and Insulin — 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 — 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.

Study Details

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 Dates

Start date
Jan 31, 2013
Status verified
Aug 2018
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIP
Albert Einstein College of Medicine West Campus CRCThe BronxNew York10467

Find similar trials in The Bronx, NY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Albert Einstein College of Medicine West Campus CRC· The Bronx, NY

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