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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856790
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Juvenile Diabetes Research Foundation
Yale University
Information provided by (Responsible Party):
Jennifer Sherr, Yale University

Brief Summary:
"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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: ePID closed loop system Drug: liraglutide Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Closed Loop Insulin Delivery

Each participant recruited into the study will undergo two inpatient closed loop admissions.

The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.

Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.

Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.

Device: ePID closed loop system
Insulin pump controlled by closed loop unit and algorithm

Drug: liraglutide
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
Other Name: Victoza

Primary Outcome Measures :
  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 Outcome Measures :
  1. the Incremental Meal-related Glucose Area Under Curve (AUC) [ Time Frame: 5-hour post prandial period after breakfast, lunch, and dinner ]

Other Outcome Measures:
  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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age 18-40 years
  2. clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
  3. duration of T1D ≥ 1 year
  4. HbA1c ≤ 9 %
  5. Treated with CSII for at least 3 months
  6. Body weight > 50 kg (to accommodate phlebotomy)
  7. 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:

  1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
  2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  3. 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
  4. History of hypoglycemic seizure within last 3 months
  5. Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
  6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
  7. History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
  8. Taking a medication known to affect gastric motility
  9. History of pancreatitis, gallstones, alcoholism or high triglyceride levels
  10. Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
  11. Subjects unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856790

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Jennifer Sherr
Juvenile Diabetes Research Foundation
Yale University
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Principal Investigator: Jennifer Sherr, MD, PhD Yale University
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Responsible Party: Jennifer Sherr, Instructor, Yale University Identifier: NCT01856790    
Other Study ID Numbers: 1211011156
First Posted: May 17, 2013    Key Record Dates
Results First Posted: January 30, 2020
Last Update Posted: January 30, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists