Safety and effectiveness of insulin detemir in combination with oral antidiabetic agents in an outpatient specialist setting: results of the Italian SOLVE (TM) observational study

Aim. The addition of basal insulin to oral anti diabetics (OADs) is described by a large number of guidelines and commonly used in clinical practice as a way to start insulin therapy in patients with type 2 diabetes mellitus in order to maximize compliance and minimise the impact of side effects (mainly hypoglycemia and body weight increase).Methods. SOLVE (TM) was a 24-week 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 patients with type 2 diabetes mellitus (T2DM) already treated with one or more OADs. The Italian arm of the SOLVE (TM) Study aimed to evaluate the safety and the effectiveness of once-daily insulin detemir in combination with OAD 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 hypoglycemic 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 patients were: age 66.5 (+/-10.0) years, duration of diabetes 13.25 (+/-8.14) years, weight 78.95 (+/-15.86) kg and BMI 29.5 (+/-5.0) kg/m(2). At the end of the study, 3 SADRs (of which 2 were major hypoglycemia) were reported in 2 patients (<0.1%). The percentage of patients with at least 1 minor hypoglycemic event during the 4 weeks preceding insulin initiation was 3.6%. Following insulin initiation, 5.7% (as recorded at baseline visit) had at least 1 minor hypoglycemic event, which decreased slightly by the end of the study compared to baseline (4.8%). In addition, before insulin initiation the mean (+/-SD) glycemic control values were: fasting plasma glucose (FPG) 11.43 (+/-3.2) mmol/L and HbA(1c) 9.16% (+/-1.46). At the end of the study, HbA(1c) 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 HbA(1c) <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<35;-2.1 kg for BMI<35).Conclusion. 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 glycemic control after initiation with insulin detemir was clinically significant and did not cause an increase in body weight or hypoglycemia.