New Lira

Treatment with GLP-1 receptor agonists has been shown to improve glycaemic control in persons with type 2 diabetes. In animal and human studies, GLP-1 receptor agonists have displayed beneficial effects on pancreatic beta-cell function that could be of interest in relation to persons with type 1 diabetes.

A cure for type 1 diabetes may include halting the autoimmune insult to the pancreatic beta-cells and restoring insulin secretion by expanding beta-cell mass by beta-cell-regeneration and/or preventing beta-cell apoptosis induced by cytokines. Immunosuppression initiated at the onset of type 1 diabetes has been shown to preserve beta-cell function, but is associated with significant toxicities. Other studies using nicotinamide and parenteral insulin have failed to prevent development of type 1 diabetes.

Aim
To investigate the effect on beta cell function of 1.8 mg liraglutide, a GLP-1 receptor agonist once daily as an adjunct to insulin treatment in persons with newly diagnosed type 1 diabetes 

Design and method
A 52-week investigator initiated, randomised, double-blind, placebo-controlled, parallel group trial

Target group
Persons diagnosed with type 1 diabetes within the last 6 weeks

Expected ending and outcome
The study is expected to end March 2018.

Primary endpoint: 

Change in beta-cell function measured by the area under the C-peptide curve to a sustacal meal from randomisation to the end of treatment.

Secondary endpoints:
Change in the following parameters from randomisation to the end of treatment:  
  • Maximal postprandial C-peptide concentration following sustacal meal test 
  • Incremental C-peptide response following sustacal meal test  
  • Beta-cell sensitivity to glucose during the sustacal meal test as estimated by use of mathematical modelling  
  • Glucagon response following sustacal meal test 
  • Daily insulin dose 
  • HbA1c  
  • Self-monitored blood glucose (SMBG) profile  
  • Fasting and postprandial lipid profile following sustacal meal test  
  • Weight 
  • Waist circumference  
  • Quality of life 

Collaborators 
Hvidovre Hospital
Bispebjerg Hospital
Hillerød Hospital
Køge Hospital
Odense Hospital

Sidst opdateret 11-07-2016

Responsible

Thomas F. Dejgaard, 
MD, PhD student
Steno Clinic