Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study.

PURPOSE: To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany. METHODS: Liraglutide/insulin-naïve adults with type 2 diabetes and inadequate glycemic control despite using oral antidiabetic medication were assigned to liraglutide (≤1.8 mg daily; n=878) or any insulin (n=382) according to the treating physician's decision and followed for 52 weeks. The primary objective was to evaluate Audit of Diabetes-Dependent Quality of Life (ADDQoL) scores. RESULTS: At baseline, the liraglutide group was younger and had shorter type 2 diabetes duration, lower glycated hemoglobin (HbA), higher body mass index, and a lower prevalence of certain diabetes-related complications than the insulin group (all p<0.05). ADDQoL average weighted impact scores improved numerically in both groups from baseline to 52 weeks (mean difference [95% confidence interval], liraglutide vs. insulin: 0.159 [-0.023;0.340]; not significant). Changes in general wellbeing and five ADDQoL domains significantly favored liraglutide (remaining 14 domains, not significant). HbA reductions were greater with insulin than liraglutide (-2.0% vs. -1.2%; p<0.01); however, mean HbA after 52 weeks was 7.2% in both groups. Compared with insulin, liraglutide significantly decreased body mass index (-1.54 kg/m vs. +0.27 kg/m; p<0.001), systolic blood pressure (-5.03 mmHg vs. -1.03 mmHg; p<0.01) and non-severe hypoglycemia (0.85% vs. 4.55% at 52 weeks; p<0.01). Adverse drug reactions were reported for<3% of patients in both groups. CONCLUSIONS: Liraglutide improved certain ADDQoL components and reduced body mass index, systolic blood pressure, and non-severe hypoglycemia versus insulin. Both treatments improved glycemic control.