Trial Outcomes & Findings for Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting (NCT NCT01755416)

NCT ID: NCT01755416

Last Updated: 2018-08-21

Results Overview

Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 0-1500 min
• Results posted on: 2018-08-21

Participant Flow

20 participants were screened. However only 18 participants were enrolled into the study. Of these 15 participants completed both study visits. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.

Participant milestones

Measure	Closed Loop/Insulin First,Then Closed Loop/Insulin/Liraglutide Participants underwent Closed Loop with Insulin first, as a continuous subcutaneous infusion for 2 days. Then they underwent the closed loop with Insulin and Liraglutide; insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the next 2 days. Each visit is 10 days apart.	Closed Loop/Insulin/Liraglutide First,Then Closed Loop/Insulin Participants underwent Closed Loop with Insulin and Liraglutide first, insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the first 2 days. Then they underwent the closed loop with Insulin alone, as a continuous subcutaneous infusion for the next 2 days. Each visit is 10 days apart.
First Intervention ( Upto 2 Days) STARTED	9	9
First Intervention ( Upto 2 Days) COMPLETED	8	7
First Intervention ( Upto 2 Days) NOT COMPLETED	1	2
Second Intervention (Upto 2 Days) STARTED	8	7
Second Intervention (Upto 2 Days) COMPLETED	8	7
Second Intervention (Upto 2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Closed Loop/Insulin First,Then Closed Loop/Insulin/Liraglutide Participants underwent Closed Loop with Insulin first, as a continuous subcutaneous infusion for 2 days. Then they underwent the closed loop with Insulin and Liraglutide; insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the next 2 days. Each visit is 10 days apart.	Closed Loop/Insulin/Liraglutide First,Then Closed Loop/Insulin Participants underwent Closed Loop with Insulin and Liraglutide first, insulin as a continuous subcutaneous infusion and liraglutide as a single daily subcutaneous injection of 1.2 mg for the first 2 days. Then they underwent the closed loop with Insulin alone, as a continuous subcutaneous infusion for the next 2 days. Each visit is 10 days apart.
First Intervention ( Upto 2 Days) Withdrawal by Subject	1	2

Baseline Characteristics

Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Baseline characteristics by cohort

Measure	All Study Participants n=18 Participants Participants who were randomized to receive either Closed Loop/Insulin subcutaneously or Closed Loop /Insulin/Liraglutide; 1.2 mg of Liraglutide subcutaneously as a single daily injection and insulin as a continuous subcutaneous infusion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26 Years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-1500 min

Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)

Outcome measures

Measure	Closed Loop/Insulin n=15 Participants Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days	Closed Loop/Insulin/Liraglutide n=15 Participants Participants on Closed Loop with Insulin and Liraglutide, insulin as a continuous subcutaneous infusion and Liraglutide as a single daily subcutaneous injection of 1.2 mg for 2 days
Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone	159.7 mg/dl Standard Deviation 50.9	144.6 mg/dl Standard Deviation 36.3

Adverse Events

Closed Loop/Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Closed Loop/Insulin/Liraglutide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rubina Heptulla

Children's Hospital at Montefiore

Phone: 718-920-7004

Email: rheptull@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place