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-naive 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 (HbA1c), 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(1c) reductions were greater with insulin than liraglutide (-2.0 % vs. -1.2 %; p < 0.01); however, mean HbA(1c) after 52 weeks was 7.2 % in both groups. Compared with insulin, liraglutide significantly decreased body mass index (-1.54kg/m(2) vs. +0.27 kg/m(2); 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.