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

NCT01856790 | Completed Early Phase 1 Results DMC

• 1 other identifier: 1211011156
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Peak Post-prandial Venous Glucose Levels

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

  48 hours

Secondary Outcomes (1)

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

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

Other Outcomes (8)

• Mean 24-hour Glucose Levels

  24- hours

• Mean Time to Peak Post-meal Glucose Value

  5- hour postprandial period

• Mean Daytime Glucose Levels

  8a.m.-11p.m.

Study Arms (1)

Closed Loop Insulin Delivery

EXPERIMENTAL

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; Drug: liraglutide

Interventions

ePID closed loop system DEVICE

Insulin pump controlled by closed loop unit and algorithm

Closed Loop Insulin Delivery

liraglutide DRUG

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

Also known as: Victoza

Closed Loop Insulin Delivery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Sherr: lead
• Juvenile Diabetes Research Foundation: collaborator
• Yale University: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Jennifer Sherr
• Organization: Yale University School of Medicine

jennifer.sherr@yale.edu

203-785-5831

Study Officials

• Jennifer Sherr, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 30, 2020
• Results First Posted: January 30, 2020

Record last verified: 2020-01

Locations

US (1)