Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

This study has been terminated.
(The decision to close the NN2211-3619 trial was based on the very low recruitment rate as well as challenges relating to trial execution and study completion.)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01206101
First received: September 20, 2010
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: June 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Interventions: Drug: liraglutide
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The trial was conducted at 3 sites in 3 countries:

Canada: 1 site; Switzerland: 1 site; US: 1 site.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All the subjects were on pre-trial insulin at screening.

Reporting Groups
  Description
Liraglutide Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
Liraglutide Placebo Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.

Participant Flow:   Overall Study
    Liraglutide     Liraglutide Placebo  
STARTED     2     1  
COMPLETED     0     0  
NOT COMPLETED     2     1  
Adverse Event                 1                 0  
Physician Decision                 0                 1  
Unclassified                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Liraglutide Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
Liraglutide Placebo Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
Total Total of all reporting groups

Baseline Measures
    Liraglutide     Liraglutide Placebo     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     1     0     1  



  Outcome Measures
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1.  Primary:   Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant   [ Time Frame: At week 52 after initial transplantation ]

2.  Secondary:   Number of Hypoglycaemic Episodes   [ Time Frame: During week 0 to week 52 ]

3.  Secondary:   Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events   [ Time Frame: From week 0 to week 52 after initial transplantation ]

4.  Secondary:   Proportion of Insulin-Independent Subjects   [ Time Frame: At 52 weeks after initial transplantation ]

5.  Secondary:   Change in Islet Cell Yield During Culture   [ Time Frame: From 0 hours pre-culture to 24 hours to 72 hours ]

6.  Secondary:   Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)   [ Time Frame: At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no results are available.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01206101     History of Changes
Other Study ID Numbers: NN2211-3619, 2009-013090-18, U1111-1114-8952
Study First Received: September 20, 2010
Results First Received: June 2, 2014
Last Updated: June 2, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Switzerland: Swissmedic