EARLY_Phase 1 · Liraglutide

NCT01856790 trial results

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

Peak Post-prandial Venous Glucose Levels (mg/dL), 48 hours. Closed Loop Insulin Delivery: 98; Closed Loop + Liraglutide: 76.

Participants
15
Status
completed
Completed
2015-11
Sponsor
Jennifer Sherr

As posted on ClinicalTrials.gov (NCT01856790), updated at source Jan 30, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01856790 measured first

Peak Post-prandial Venous Glucose Levelsmg/dL · 48 hours · mean
Closed Loop Insulin Deliveryn=11Closed Loop + Liraglutiden=11
98(24)76(17)
Side effects by arm

Side effects in NCT01856790

Percent of participants affected. The most common events the registry lists.

EventClosed Loop OnlyClosed Loop + Liraglutide
Any serious event0%0%
gastrointestinal distress0%54.5%
headache0%54.5%
Secondary outcomes

What else it measured

the Incremental Meal-related Glucose Area Under Curve (AUC)mg*hr/dL · 5-hour post prandial period after breakfast, lunch, and dinner · mean
Closed Loop Insulin Deliveryn=11Closed Loop + Liraglutiden=11
789(176)500(151)
The trial

How NCT01856790 was run

"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.

  • 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...
Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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