Early Phase 1
N=15
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01856790 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Peak Post-prandial Venous Glucose Levels — 98; 76 mg/dL — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- ePID closed loop system (Device); liraglutide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jennifer Sherr
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Post-prandial Venous Glucose Levels |
98; 76 | 0.05 |
| SECONDARY the Incremental Meal-related Glucose Area Under Curve (AUC) |
789; 500 | 0.002 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01856790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.