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Introduction Most data demonstrating the efficacy and safety of luseogliflozin (luseo) in people with type 2 diabetes mellitus (T2DM) originate from the Japanese population. This study evaluated luseo versus placebo (PCB) as add-on to metformin in a Caucasian population with inadequately controlled T2DM.Research design and methods This was a multicenter, randomized, double-blind, PCB-controlled, parallel-group study. Patients aged 18–75 years with inadequately controlled T2DM (glycated hemoglobin (HbA1c) ≥7% to ≤10% (≥53 to ≤86 mmol/mol)) despite a diet and exercise program and on a stable metformin regimen were eligible. Patients were randomized to one of three luseo groups (2.5, 5.0 and 10.0 mg) or PCB for 12 weeks (W12). The primary endpoint was change in HbA1c expressed as least-square means from baseline (W0) to W12.Results A total of 328 patients were randomized: PCB (n=83) and luseo 2.5 mg (n=80), 5.0 mg (n=86), and 10.0 mg (n=79). Mean age (±SD) was 58.5±8.8 years; 64.6% were women; body mass index was 31.5±3.4 kg/m2; and HbA1c was 8.54±0.70. At W12, mean reductions in HbA1c from W0 were −0.98%, −1.09%, −1.18%, and −0.73% in the luseo 2.5, 5.0 and 10.0 mg, and PCB groups, respectively, all of which were statistically significant. Compared with PCB, HbA1c levels were significantly decreased by 0.25% (p=0.045), 0.36% (p=0.006), and 0.45% (p=0.001) in the luseo 2.5, 5.0, and 10.0 mg groups, respectively. In all luseo dose groups, reductions in body weight were statistically significant compared with PCB. Data from the safety analysis were consistent with the known luseo safety profile.Conclusions All doses of luseo as add-on to metformin in Caucasian patients with uncontrolled T2DM demonstrated significant efficacy in decreasing HbA1c after W12 of treatment.Trial registration number ISRCTN39549850.

Currently, the leading place in the structure of morbidity in older people takes the cardiovascular disease. It is also the leading cause of death in developed countries. The significance of osteoporosis is now also due to the high and growing prevalence of this pathology. Osteoporotic fractures are associated with a reduction in the quality of life in patients, lead to disability, require a significant investment. This pathology is ranked fourth in the structure of mortality after cardiovascular disease, oncopathology, and diabetes.Numerous studies indicate that these two diseases are associated not only with the occurrence of age, but have common pathogenetic mechanisms. The data obtained suggest that osteoporosis, calcification of the aorta and heart valves and atherosclerotic vascular disease – related pathological processes. Vascular and bone have some common morphological properties, vascular calcification and consists of the same components as the bone tissue.From the standpoint of modern medicine it is extremely important to identify specific relationships between diseases and their common pathogenetic mechanisms for development of a comprehensive and individual approach to the diagnosis, treatment and prevention.