Projecting the Long-Term Clinical Benefits of Treatment with the GLP-1 Analogue Liraglutide in Subjects with Type 2 Diabetes.

An international, 14-week phase 2b clinical trial with type 2 diabetes treated with diet or monotherapy reported improved glyceamic control with different doses of liraglutide compared to placebo. Liraglutide, a once daily GLP-1 analogue, was associated with improvements in HbA1c between 1.27% and 1.74% from baseline, compared to an increase of 0.25% with placebo. Liraglutide was also associated with reductions in BMI. The CORE Diabetes Model was used to project the long-term clinical outcomes associated with three different daily doses of liraglutide (0.65, 1.25 and 1.9 mg) versus placebo. The model simulates the progression of diabetes and its complications. Mean baseline cohort characteristics from the phase 2b trial were used in the analysis (age 55.8 years, HbA1c 7.9%-points, BMI 30.1 kg/m², duration of diabetes 6.2 years). Once the 14-week treatment effects were applied, HbA1c progression followed the trend observed in the UKPDS, for both liraglutide and placebo. Clinical outcomes were projected over a lifetime horizon and discounted at 3% annually. Compared to placebo, treatment with liraglutide was projected to improve life expectancy by 0.71, 0.84 and 0.95 life years with daily doses of 0.65 mg, 1.25 mg and 1.9 mg, respectively. Quality-adjusted life expectancy was observed to increase by 0.56, 0.66 and 0.76 quality-adjusted life years, for the respective doses versus placebo. Liraglutide was also projected to delay the development of all diabetes-related complications compared to placebo, with the onset of any complication estimated to be delayed by 0.37, 0.44 and 0.52 years with liraglutide doses of 0.65, 1.25 and 1.9 mg daily versus placebo. All three doses of liraglutide were projected to reduce the cumulative incidence of microvascular complications including peripheral vascular disease, angina, myocardial infarction and congestive heart failure compared to placebo. The results from this modeling analysis indicate that the benefits of 14 weeks of treatment with liraglutide could potentially lead to improvements in life expectancy and quality-adjusted life expectancy and a reduction in--the incidence and onset of diabetes-related complications, compared to placebo, in subjects with type 2 diabetes. [ABSTRACT FROM AUTHOR]