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Completed

NCT Number: NCT01856790

Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes

"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-40 years
  • clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
  • duration of T1D ≥ 1 year
  • HbA1c ≤ 9 %
  • Treated with CSII for at least 3 months
  • Body weight > 50 kg (to accommodate phlebotomy)
  • Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct

Exclusion criteria

  • Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
  • Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  • Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
  • History of hypoglycemic seizure within last 3 months
  • Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
  • Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
  • History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
  • Taking a medication known to affect gastric motility
  • History of pancreatitis, gallstones, alcoholism or high triglyceride levels
  • Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
  • Subjects unable to give consent

Treatment and study plan

ePID closed loop system

Device

Insulin pump controlled by closed loop unit and algorithm

liraglutide

Drug

Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Other names: Victoza

Primary outcomes

  1. Peak Post-prandial Venous Glucose Levels

    Time frame: 48 hours

    peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide

Secondary outcomes

  1. the Incremental Meal-related Glucose Area Under Curve (AUC)

    Time frame: 5-hour post prandial period after breakfast, lunch, and dinner

Other outcomes

  1. Mean 24-hour Glucose Levels

    Time frame: 24- hours

  2. Mean Time to Peak Post-meal Glucose Value

    Time frame: 5- hour postprandial period

  3. Mean Daytime Glucose Levels

    Time frame: 8a.m.-11p.m.

  4. Incremental Glucagon Peak

    Time frame: 5 hours

  5. AUC Plasma Glucagon During MMTT

    Time frame: 2 hours

  6. Differences in Daily Insulin Requirements

    Time frame: 24 hours

  7. Prandial Insulin Delivery During Closed Loop Therapy

    Time frame: Average of the 5-hour post prandial period for breakfast, lunch, dinner combined

  8. Mean Nocturnal Glucose Levels

    Time frame: 11p.m.-6a.m.

Sponsors and collaborators

Lead sponsor

Jennifer Sherr

Other

Collaborators

  • Juvenile Diabetes Research Foundation
  • Yale University

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 17, 2013
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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