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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

ePID closed loop system

liraglutide

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed Loop Insulin Delivery

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01856790

First Posted

May 14, 2013

Last Updated

January 28, 2020

Sponsor

Jennifer Sherr

Collaborators

Juvenile Diabetes Research Foundation, Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01856790

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jennifer Sherr

Collaborators

Juvenile Diabetes Research Foundation, Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Closed Loop Insulin Delivery

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ePID closed loop system

Intervention Description

Insulin pump controlled by closed loop unit and algorithm

Intervention Type

Drug

Intervention Name(s)

liraglutide

Other Intervention Name(s)

Victoza

Intervention Description

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

Primary Outcome Measure Information:

Title

Peak Post-prandial Venous Glucose Levels

Description

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Mean 24-hour Glucose Levels

Time Frame

24- hours

Title

Mean Time to Peak Post-meal Glucose Value

Time Frame

5- hour postprandial period

Title

Mean Daytime Glucose Levels

Time Frame

8a.m.-11p.m.

Title

Incremental Glucagon Peak

Time Frame

5 hours

Title

AUC Plasma Glucagon During MMTT

Time Frame

2 hours

Title

Differences in Daily Insulin Requirements

Time Frame

24 hours

Title

Prandial Insulin Delivery During Closed Loop Therapy

Time Frame

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

Title

Mean Nocturnal Glucose Levels

Time Frame

11p.m.-6a.m.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Sherr, MD, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

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

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