[Once daily insulin detemir in patients with type 2 diabetes: results of German centers in a 6-month international observational study (SOLVE)].

BACKGROUND: Hypoglycemic risk and improved glycemic control have to be weightened when a decision on intensification of treatment of type 2 diabetes mellitus with basal insulin is made. Findings from randomized studies are available in this respect, and should be complemented by data from routine treatment.

METHODS: The international, prospective, open-label, observational study SOLVE (Study of Once-Daily Levemir) investigated add-on treatment with basal insulin in type 2 diabetes mellitus using once daily insulin detemir in patients currently receiving oral antidiabetic drugs (OAD). Data were collected between initiation of insulin treatment and the final visit after approximately 24 weeks. The primary objective of the study was to evaluate the incidence of serious adverse drug reactions (SADR), including major hypoglycemic events.

RESULTS: In Germany, 2,090 patients were eligible for the full analysis set and 1,671 patients for the effectiveness analysis set. The mean age was 64.9 years, mean duration of diabetes 9.36 years, and mean duration of OAD treatment 7.29 years. Three patients (0.14%) experienced a SADR (1 fall resulting in death, 2 major hypoglycemic events). At the final visit, there was a significant reduction in major hypoglycemic events if compared with the period before starting insulin treatment (0.002 versus 0.120 events per patient year, p < 0.001), as were minor hypoglycemic events (0.880 versus 1.588 events per patient year, p = 0.006). The mean body weight and BMI decreased by -0.9 kg (p < 0.001) and-0.35 kg/m2 (p < 0.001) respectively and the mean HbA(1c) level improved from 8.45 +/- 1.19% to 7.30 +/- 0.92% (-1.15 +/- 1.08%; p < 0.001). The mean fasting plasma glucose level and plasma glucose variability were significantly reduced.

CONCLUSION: Baseline data of the study underline the need for earlier intensification of antidiabetic therapy in type 2 diabetes in Germany. Study results show that within the German diabetes care system, initiation of basal insulin therapy with insulin detemir is able to result in significant HbA(1c) improvements without increased risk of hypoglycemia and/or weight gain.