Safety and effectiveness of insulin detemir in combination with oral anti-diabetic agents in an outpatient specialist setting: results of the Italian SOLVE™ observational study.

Background. The addition of basal insulin to oral antidiabetics (OADs) is described by a large number of guidelines (26,27) and commonly used in clinical practice as a way to start insulin therapy in patient with type 2 diabetes mellitus in order to maximise compliance and minimise the impact of side effects (mainly hypoglycaemia and body weight increase). Materials and Methods. SOLVE™ was a 24-weeks international observational study conducted in 10 countries (including Italy) for the evaluation of the safety and effectiveness of once-daily insulin detemir as add-on therapy in people with T2DM already treated with one or more OADs. Aim. The Italian arm of the Solve™ Study aimed to evaluate the safety and the effectiveness of once daily insulin detemir in combination with OADs agents for the treatment of patients with T2DM in the Italian outpatient specialist setting. The primary endpoint was to assess the incidence of serious adverse drug reactions (SADRs) including in the specific major hypoglycaemic events during 24 weeks of once-daily insulin detemir treatment. Results. A total of 4625 patients were enrolled in the study by 223 Italian centres for diabetes care. At baseline the mean (±SD) demographic characteristics of the patientswere: age 66.5 (±10.0) years, duration of diabetes 13.25 (±8.14) years, weight 78.95 (±15.86) kg and BMI 29.5 kg/m2 (±5.0). At the end of the study, 3 SADRs (of which 2 major hypoglycaemia) were reported in 2 patients (<0.1%). The percentage of patients with at least 1 minor hypoglycaemic event during the 4 weeks preceding insulin initiation was 3.6%; Following insulin initiation, 5.7% (as recorded at baseline visit) at least 1 minor hypoglycaemic event, wich decreased slightly by the end of the study compared to baseline (4.8%). In addition, before insulin initiation the (±SD) glycaemic control values were: fasting plasma glucose (FPG) 11.43 (±3.2) mmol/l and HbA1c 9.16% (±1.46). At the end of the study, HbA1c was reduced by 1.35% (±1.57) (p<0.001), FPG was reduced by 3.34 mmol/l (p<0.001) and the percentage of patients (with HbA1c<7%) was 21.9%. A mean reduction of 0.52 kg of body weight (p<0.001) was observed compared to before insulin initiation; the body weight reduction was more pronounced in patients with higher BMI before insulin initiation (-1,0 kg for 30<BMI<35; -2,1 kg for BMI<35). Conclusions. In the Italian outpatient setting, once-daily insulin detemir as add-on therapy to OADs was associated with a favourable tolerability profile. The improvement of the glycaemic control after insulin initiation with insulin detemir was clinically significant and did not cause an increase in body weight or hypoglycaemia. .