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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856790
• Other study ID #: 1211011156
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• ePID closed loop system
Insulin pump controlled by closed loop unit and algorithm

Drug:
• liraglutide
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Jennifer Sherr	Juvenile Diabetes Research Foundation, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean 24-hour Glucose Levels		24- hours
Other	Mean Time to Peak Post-meal Glucose Value		5- hour postprandial period
Other	Mean Daytime Glucose Levels		8a.m.-11p.m.
Other	Incremental Glucagon Peak		5 hours
Other	AUC Plasma Glucagon During MMTT		2 hours
Other	Differences in Daily Insulin Requirements		24 hours
Other	Prandial Insulin Delivery During Closed Loop Therapy		Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
Other	Mean Nocturnal Glucose Levels		11p.m.-6a.m.
Primary	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	48 hours
Secondary	the Incremental Meal-related Glucose Area Under Curve (AUC)		5-hour post prandial period after breakfast, lunch, and dinner