Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients
on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight.
However, to date there are no clinical trials of liraglutide added to insulin therapy, a
population of patients generally having worse glycaemic control and weight gain. In clinical
guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic
option for type 2 diabetic patients.
The primary study aim is to evaluate whether the addition of liraglutide, compared to
placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with
inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is
defined as treatment with any basal insulin combined with separate meal time insulin
injections before the main meals, i.e. an insulin regimen with premixed insulin is not
considered as MDI.
The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.