Estudio observacional prospectivo con insulina detemir en pacientes con diabetes mellitus tipo 2 mal controlados que inician por primer vez tratamiento con insulina (estudio SOLVE)

OBJECTIVE: Describe the experience in the primary care setting with insulin detemir in patients with poorly controlled type 2 diabetes mellitus that need to add-on insulin to their oral antidiabetic drug therapy. METHODS: Prospective observational study of 6 months of follow up, performed in 10 countries. In Spain, participating sites were only from the primary care setting. Eligible patients were those with poorly controlled type 2 diabetes mellitus adding-on once-daily insulin detemir to their existing oral antidiabetic therapy in the month prior to their enrollment. The change of Hb1Ac and of weight at the end of the study and the incidence of hypoglycemia and adverse reactions, were analyzed. We report the results obtained in the Spanish cohort. RESULTS: Overall 17,374 patients were included, 973 in Spain [mean age 64.8 years (SE 12); duration of diabetes 9.4 years (SE 6.2); Hb1Ac 8.9% (DE 1.4)]. In the sample analyzed for efficacy (n = 474) the mean change of Hb1Ac was −1.6% (95% CI: −1.75 to −1.42; P < .001), mean change of weight was −2.9 kg (95% CI: −3.72 to −2.08; P < .001). Only one episode of severe hypoglycemia was reported, which was also the only serious adverse reaction reported in the study. The incidence rate of non-severe hypoglycemia was 2.44 events/patient-year. CONCLUSIONS: In this cohort of patients with type 2 diabetes mellitus receiving newly initiated insulin therapy, once-daily detemir improved the glycemic control, with low incidence of hypoglycemia and a significant reduction of the weight.