← Trials/Trial dossier/NCT01856790
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsPeak Post-prandial Venous Glucose Levels
Time frame:48 hours
Postprandial glucose
descriptive, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 98 | — |
| Closed Loop + Liraglutide | 76 | — |
Peak Post-prandial Venous Glucose Levels
Time frame:48 hours
Postprandial glucose
descriptive, improvement
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
| Group | Value (mean), mg*hr/dL | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 789 | — |
| Closed Loop + Liraglutide | 500 | — |
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
Mean 24-hour Glucose Levels
Time frame:24- hours
descriptive, improvement
Mean Time to Peak Post-meal Glucose Value
Time frame:5- hour postprandial period
Postprandial glucose
descriptive
Mean Daytime Glucose Levels
Time frame:8a.m.-11p.m.
descriptive, improvement
Differences in Daily Insulin Requirements
Time frame:24 hours
change from baseline, improvement
Prandial Insulin Delivery During Closed Loop Therapy
Time frame:Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
descriptive
Mean Nocturnal Glucose Levels
Time frame:11p.m.-6a.m.
descriptive, improvement
Mean 24-hour Glucose Levels
Time frame:24- hours
descriptive, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 130 | — |
| Closed Loop + Liraglutide | 135 | — |
Mean Time to Peak Post-meal Glucose Value
Time frame:5- hour postprandial period
Postprandial glucose
descriptive
Posted result
| Group | Value (mean), hours | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 1.8 | — |
| Closed Loop + Liraglutide | 1.8 | — |
Mean Daytime Glucose Levels
Time frame:8a.m.-11p.m.
descriptive
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| ePID Closed Loop System Without Liraglutide | 143 | — |
| ePID Closed Loop System With Liraglutide | 146 | — |
Incremental Glucagon Peak
Time frame:5 hours
descriptive
Posted result
| Group | Value (mean), pg/mL/min | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 29 | — |
| Closed Loop + Liraglutide | 35 | — |
AUC Plasma Glucagon During MMTT
Time frame:2 hours
concentration, improvement
Posted result
| Group | Value (mean), pg*min/mL | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 1904 | — |
| Closed Loop + Liraglutide | 1801 | — |
Differences in Daily Insulin Requirements
Time frame:24 hours
change from baseline, improvement
Posted result
| Group | Value (mean), units | 95% CI |
|---|---|---|
| Pre-Liraglutide Treatment | 51.5 | — |
| Post-Liraglutide Treatment | 37.5 | — |
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
| Group | Value (mean), units | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 22.6 | — |
| Closed Loop + Liraglutide | 16.3 | — |
Mean Nocturnal Glucose Levels
Time frame:11p.m.-6a.m.
descriptive
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Closed Loop Insulin Delivery | 104 | — |
| Closed Loop + Liraglutide | 113 | — |
Other (unclassified)
2 endpointsIncremental Glucagon Peak
Time frame:5 hours
descriptive
AUC Plasma Glucagon During MMTT
Time frame:2 hours
concentration, descriptive
Provenance
Sources
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.