title: ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Endocrinology and Diabetology, Université catholique de Louvain, University Clinic St-Luc, Brussels, Belgium. Electronic address: martin.buysschaert@uclouvain.be.
authors.forename: Martin
authors.initials: M
authors.lastname: Buysschaert
authors.affiliation: Novo Nordisk Pharma Belux, Brussels, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: D'Hooge
authors.affiliation: Department of Endocrinology and Diabetology, Université catholique de Louvain, University Clinic St-Luc, Brussels, Belgium.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Preumont
mesh_terms: D000368:Aged; D001530:Belgium; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D000069450:Liraglutide / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; D000069450:Liraglutide; D008687:Metformin; D000077205:Pioglitazone
keywords: Adverse drug reactions; Dosage; HbA1c; Liraglutide; Type 2 diabetes; Weight