ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients

Abstract

Aims: The ROOTS study was an observational study to evaluate the effectiveness and safety of liraglutide (Victoza(®)), a GLP-1 receptor analog, in a cohort of patients with type 2 diabetes with inadequate glycaemic control despite conventional antihyperglycaemic dual therapy. The primary objective was to assess glycaemic control while using liraglutide under normal clinical practice conditions. The primary endpoint was to estimate the proportion of patients achieving improved glycaemic control defined as a HbA1c<7% or with a decrease of ≥1% after 12 months.

Material and methods: The study included 245 subjects. They received liraglutide in addition to their usual dual therapy (metformin and sulfonylureas or pioglitazone). Age and duration (mean±SD) of diabetes were 58±10 and 9±5 years respectively. Body mass index was 33.9±6.2 kg/m(2).

Results: HbA1c decreased from 9.12%±1.28 at baseline to 7.54%±1.12 after one year follow-up (p<0.001). The primary endpoint was achieved in 66.5% of patients. In parallel, we observed a reduction of BMI from baseline 33.9±6.2 to 32.8±6.3 kg/m(2) (p<0.001). At 12 months, 64.6% of the patients received liraglutide at a dosage of 1.2 mg/day, 32.7% received 1.8 mg and 2.7% 0.6 mg. Adverse drug reactions were present in 24% of subjects, most frequently gastrointestinal disorders (11.4%), mainly nausea (6.9%) and no pancreatic events.

Conclusions: Treatment with liraglutide was associated with a marked improvement in glycaemic control in daily routine practice as well as with a reduction of weight, without major side effects.

Keywords: Adverse drug reactions; Dosage; HbA1c; Liraglutide; Type 2 diabetes; Weight.