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CompletedPhase EARLY_1Results posted

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

Lead sponsor

Jennifer Sherr

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

15

actual

Study population

Type 1 diabetes

Key I/E criterion

HbA1c ≤9%

Primary endpoint

Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01856790
Org study ID1211011156

Timeline

Milestones

Study first posted2013-05-17estimated
Last update posted2020-01-30actual
Results first posted2020-01-30actual
Study start2013-02 (month precision)
Primary completion2015-11actual (month precision)
Study completion2015-11actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
18
Other (unclassified)
2

Glycemic / diabetes

18 endpoints
Primary/registry result

Peak Post-prandial Venous Glucose Levels

Time frame:48 hours

Postprandial glucose

descriptive, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Closed Loop Insulin Delivery98
Closed Loop + Liraglutide76
p0.05Wilcoxon Matched Pairs signed rank tests
Primary/protocol endpoint

Peak Post-prandial Venous Glucose Levels

Time frame:48 hours

Postprandial glucose

descriptive, improvement

Secondary/registry result

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

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

Postprandial glucose

concentration, improvement

Posted result

GroupValue (mean), mg*hr/dL95% CI
Closed Loop Insulin Delivery789
Closed Loop + Liraglutide500
p0.002Wilcoxon Matched Pairs signed rank tests
Secondary/protocol endpoint

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

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

Postprandial glucose

descriptive, improvement

Other/protocol endpoint

Mean 24-hour Glucose Levels

Time frame:24- hours

descriptive, improvement

Other/protocol endpoint

Mean Time to Peak Post-meal Glucose Value

Time frame:5- hour postprandial period

Postprandial glucose

descriptive

Other/protocol endpoint

Mean Daytime Glucose Levels

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

descriptive, improvement

Other/protocol endpoint

Differences in Daily Insulin Requirements

Time frame:24 hours

change from baseline, improvement

Other/protocol endpoint/low confidence

Prandial Insulin Delivery During Closed Loop Therapy

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

descriptive

Other/protocol endpoint

Mean Nocturnal Glucose Levels

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

descriptive, improvement

Other_pre_specified/registry result

Mean 24-hour Glucose Levels

Time frame:24- hours

descriptive, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Closed Loop Insulin Delivery130
Closed Loop + Liraglutide135
Other_pre_specified/registry result

Mean Time to Peak Post-meal Glucose Value

Time frame:5- hour postprandial period

Postprandial glucose

descriptive

Posted result

GroupValue (mean), hours95% CI
Closed Loop Insulin Delivery1.8
Closed Loop + Liraglutide1.8
p0.97Wilcoxon Matched Pairs signed rank tests
Other_pre_specified/registry result

Mean Daytime Glucose Levels

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

descriptive

Posted result

GroupValue (mean), mg/dL95% CI
ePID Closed Loop System Without Liraglutide143
ePID Closed Loop System With Liraglutide146
Other_pre_specified/registry result/low confidence

Incremental Glucagon Peak

Time frame:5 hours

descriptive

Posted result

GroupValue (mean), pg/mL/min95% CI
Closed Loop Insulin Delivery29
Closed Loop + Liraglutide35
Other_pre_specified/registry result

AUC Plasma Glucagon During MMTT

Time frame:2 hours

concentration, improvement

Posted result

GroupValue (mean), pg*min/mL95% CI
Closed Loop Insulin Delivery1904
Closed Loop + Liraglutide1801
Other_pre_specified/registry result/low confidence

Differences in Daily Insulin Requirements

Time frame:24 hours

change from baseline, improvement

Posted result

GroupValue (mean), units95% CI
Pre-Liraglutide Treatment51.5
Post-Liraglutide Treatment37.5
p.001Wilcoxon Matched Pairs signed rank tests
Other_pre_specified/registry result/low confidence

Prandial Insulin Delivery During Closed Loop Therapy

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

descriptive

Posted result

GroupValue (mean), units95% CI
Closed Loop Insulin Delivery22.6
Closed Loop + Liraglutide16.3
p0.005Wilcoxon Matched Pairs signed rank tests
Other_pre_specified/registry result

Mean Nocturnal Glucose Levels

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

descriptive

Posted result

GroupValue (mean), mg/dL95% CI
Closed Loop Insulin Delivery104
Closed Loop + Liraglutide113

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Incremental Glucagon Peak

Time frame:5 hours

descriptive

Other/protocol endpoint/low confidence

AUC Plasma Glucagon During MMTT

Time frame:2 hours

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.