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

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.

Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results.

OBJECTIVE: To investigate the safety and efficacy of switching to biphasic insulin aspart (BIAsp) 30, 50 or 70 in patients with type 2 diabetes previously treated with biphasic human insulin (BHI) 30/50 (with or without oral glucose-lowering drugs) in routine clinical practice. METHODS: This was a 26-week, prospective, observational study conducted in Belgium and Luxembourg. Data were collected at baseline before patients switched and at 12 and 26 weeks after starting BIAsp 30, 50 or 70. Safety endpoints were incidence and rate of hypoglycemia (major, minor, nocturnal), adverse events and body-weight changes. Efficacy assessments included HbA(1c) and 7-point self-measured plasma glucose (PG) profiles. Changes from baseline were analyzed using paired t-tests. RESULTS: Of 592 patients analyzed, 72% switched to twice-daily BIAsp and 20% to three-times daily BIAsp. Upon switching, 27% of patients received intensified treatment (i.e., more daily doses than with their previous BHI). At all three data-collection points, approximately two-thirds of patients were taking BIAsp 30 and approximately one-third were taking BIAsp 50; very few patients took BIAsp 70. Mean total daily insulin dose increased significantly from baseline (51.2 U) to 26 weeks (54.3 U) and mean time of intake before meals changed from 17 minutes for BHI to ∼3 minutes with BIAsp. Incidence of hypoglycemia did not change during the study (baseline: 30.7%, week 26: 29.2%). HbA(1c) improved significantly from baseline (7.9 %) to weeks 12 and 26 (7.6% and 7.5%, respectively; p < 0.001). Mean PG profiles also showed significant improvements. As this is an observational study, some limitations should be considered such as the absence of a control group and a possible bias of increased medical attention. CONCLUSIONS: Patients with long-standing type 2 diabetes can switch safely from BHI to BIAsp therapy, even if they receive intensified treatment, and they have no problems changing the timing of their insulin injections.