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CompletedNCT01856790Updated Jan 30, 2020Results posted

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

An Early Phase 1 interventional study of ePID closed loop system and liraglutide in Type 1 Diabetes, sponsored by Jennifer Sherr. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Jennifer Sherr · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 15 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

This is the only study on the registry with Jennifer Sherr as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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 · Drug: liraglutide

Interventions

  • DeviceePID closed loop system

    Insulin pump controlled by closed loop unit and algorithm

  • Drugliraglutide

    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

06

What researchers measure

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

    Time frame: 48 hours

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.

07

Results

Posted Jan 30, 2020

Participant flow

Closed Loop Control
Participant flow — Closed Loop Control
MilestoneAll Study Participants
Started15
Completed13
Not completed2
Withdrew: Withdrawal by subject2
Closed Loop Control + Liraglutide
Participant flow — Closed Loop Control + Liraglutide
MilestoneAll Study Participants
Started13
Completed11
Not completed2
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryPeak 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

Time frame:
48 hours
Reported as:
Mean · mg/dL
Peak Post-prandial Venous Glucose Levels
mg/dLClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Peak Post-prandial Venous Glucose Levels98 ± 2476 ± 17
Statistical analysis
  • Closed Loop Insulin Delivery vs Closed Loop + Liraglutide · Wilcoxon Matched Pairs signed rank tests · p = 0.05
Secondarythe Incremental Meal-related Glucose Area Under Curve (AUC)
Time frame:
5-hour post prandial period after breakfast, lunch, and dinner
Reported as:
Mean · mg*hr/dL
the Incremental Meal-related Glucose Area Under Curve (AUC)
mg*hr/dLClosed Loop Insulin DeliveryClosed Loop + Liraglutide
the Incremental Meal-related Glucose Area Under Curve (AUC)789 ± 176500 ± 151
Statistical analysis
  • Closed Loop Insulin Delivery vs Closed Loop + Liraglutide · Wilcoxon Matched Pairs signed rank tests · p = 0.002
Other pre-specifiedMean 24-hour Glucose Levels
Time frame:
24- hours
Reported as:
Mean · mg/dL
Mean 24-hour Glucose Levels
mg/dLClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Mean 24-hour Glucose Levels130 ± 51135 ± 45
Other pre-specifiedMean Time to Peak Post-meal Glucose Value
Time frame:
5- hour postprandial period
Reported as:
Mean · hours
Mean Time to Peak Post-meal Glucose Value
hoursClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Mean Time to Peak Post-meal Glucose Value1.8 ± 0.51.8 ± 0.6
Statistical analysis
  • Closed Loop Insulin Delivery vs Closed Loop + Liraglutide · Wilcoxon Matched Pairs signed rank tests · p = 0.97
Other pre-specifiedMean Daytime Glucose Levels
Time frame:
8a.m.-11p.m.
Reported as:
Mean · mg/dL
Mean Daytime Glucose Levels
mg/dLePID Closed Loop System Without LiraglutideePID Closed Loop System With Liraglutide
Mean Daytime Glucose Levels143 ± 55146 ± 47
Other pre-specifiedIncremental Glucagon Peak
Time frame:
5 hours
Reported as:
Mean · pg/mL/min
Incremental Glucagon Peak
pg/mL/minClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Incremental Glucagon Peak29 ± 1635 ± 20
Other pre-specifiedAUC Plasma Glucagon During MMTT
Time frame:
2 hours
Reported as:
Mean · pg*min/mL
AUC Plasma Glucagon During MMTT
pg*min/mLClosed Loop Insulin DeliveryClosed Loop + Liraglutide
AUC Plasma Glucagon During MMTT1904 ± 6511801 ± 906
Other pre-specifiedDifferences in Daily Insulin Requirements
Time frame:
24 hours
Reported as:
Mean · units
Differences in Daily Insulin Requirements
unitsPre-Liraglutide TreatmentPost-Liraglutide Treatment
Differences in Daily Insulin Requirements51.5 ± 1437.5 ± 12.9
Statistical analysis
  • Pre-Liraglutide Treatment vs Post-Liraglutide Treatment · Wilcoxon Matched Pairs signed rank tests · p = .001
Other pre-specifiedPrandial Insulin Delivery During Closed Loop Therapy
Time frame:
Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
Reported as:
Mean · units
Prandial Insulin Delivery During Closed Loop Therapy
unitsClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Prandial Insulin Delivery During Closed Loop Therapy22.6 ± 8.416.3 ± 8.3
Statistical analysis
  • Closed Loop Insulin Delivery vs Closed Loop + Liraglutide · Wilcoxon Matched Pairs signed rank tests · p = 0.005
Other pre-specifiedMean Nocturnal Glucose Levels
Time frame:
11p.m.-6a.m.
Reported as:
Mean · mg/dL
Mean Nocturnal Glucose Levels
mg/dLClosed Loop Insulin DeliveryClosed Loop + Liraglutide
Mean Nocturnal Glucose Levels104 ± 23113 ± 24

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Closed Loop Only—0/13 (0%)0/13 (0%)
Closed Loop + Liraglutide—0/11 (0%)6/11 (54.5%)
Most frequent other events
Most frequent other events
EventClosed Loop OnlyClosed Loop + Liraglutide
gastrointestinal distressGastrointestinal disorders0/136/11
headacheNervous system disorders0/136/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Baseline Subject Characteristics
Mean22 ± 3.4
Sex: Female, Male
Sex: Female, Male(Participants)Baseline Subject Characteristics
Female7
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Baseline Subject Characteristics
Hispanic or Latino1
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Baseline Subject Characteristics
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White11
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Yale University School of Medicine
    New Haven, Connecticut 06520, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2020, 4 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2013
First posted
May 17, 2013
Start
Feb 2013
Primary completionActual
Nov 2015
CompletionActual
Nov 2015
Results first posted
Jan 30, 2020
Last update
Jan 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01856790
Lead sponsor
Jennifer Sherr
Collaborators
Juvenile Diabetes Research Foundation, Yale University
Responsible party
Jennifer Sherr (Instructor, Yale University) — Sponsor-investigator
First posted
May 17, 2013
Start date
Feb 2013
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Jan 30, 2020
Last update
Jan 30, 2020

Study contacts

Jennifer Sherr, MD, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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