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Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

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ClinicalTrials.gov Identifier: NCT01755416
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Closed loop with sensor and Insulin
Drug: Closed loop with sensor, Insulin and Liraglutide
Enrollment 18
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Closed Loop/Insulin First,Then Closed Loop/Insulin/Liraglutide Closed Loop/Insulin/Liraglutide First,Then Closed Loop/Insulin
Hide Arm/Group Description 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. 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.
Period Title: First Intervention ( Upto 2 Days)
Started 9 9
Completed 8 7
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
Period Title: Second Intervention (Upto 2 Days)
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 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
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
26  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
10
  55.6%
Male
8
  44.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
 100.0%
1.Primary Outcome
Title Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
Hide Description 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)
Time Frame 0-1500 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop/Insulin Closed Loop/Insulin/Liraglutide
Hide Arm/Group Description:
Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days
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
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dl
159.7  (50.9) 144.6  (36.3)
Time Frame 12 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Closed Loop/Insulin Closed Loop/Insulin/Liraglutide
Hide Arm/Group Description Participants on Closed Loop with Insulin as a continuous subcutaneous infusion for 2 days. 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
All-Cause Mortality
Closed Loop/Insulin Closed Loop/Insulin/Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Closed Loop/Insulin Closed Loop/Insulin/Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Closed Loop/Insulin Closed Loop/Insulin/Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rubina Heptulla
Organization: Children's Hospital at Montefiore
Phone: 718-920-7004
EMail: rheptull@montefiore.org
Layout table for additonal information
Responsible Party: Rubina Heptulla, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01755416     History of Changes
Other Study ID Numbers: 2012-503
First Submitted: November 21, 2012
First Posted: December 24, 2012
Results First Submitted: February 28, 2018
Results First Posted: August 21, 2018
Last Update Posted: August 21, 2018