Effect of bifidobacterium tetragenous viable bacteria tablets on blood glucose level in patients with type 2 diabetes mellitus

Objective To explore the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets (BTVBT) in blood glucose control in patients with type 2 diabetes mellitus (T2DM). Methods This study was a randomized, double-blind, placebo parallel comparison, multicentre clinical research. The subjects were T2DM patients who were using anti-hyperglycemic drugs. They were randomly divided into observation group and control group according to 1∶1 ratio. The subjects accepted the therapy of BTVBT or placebo by oral administration (3 tablets, tid) for eight weeks, followed up for 4 weeks, during which the basic treatment maintained unchanged. The primary outcomes: the changes of glycosylate hemoglobin A1c (HbA1c) from baseline. Results Totally 234 subjects (116 cases in observation group and 118 cases in control group) from 7 centers were included in the study. The baseline characteristics were comparable between these two groups. The HbA1c was (8.00±1.08)% and (7.99±1.03)% in observation group and control group, respectively, at baseline, and was (7.28±1.28)% and (7.36±1.02)% after 12 weeks of treatment [(-0.66±1.38)% vs. (-0.64±1.14)%, P=0.914 5]. The secondary outcomes were as follows: the fasting blood glucose (FBG) in the observation group were (7.91±1.87)mmol/L and (8.05±2.33)mmol/L at baseline and after 12 weeks of treatment; while in the control group, the FBG were (8.51±1.68)mmol/L and (8.00±2.02)mmol/L, and comparisons between two groups showed no significant change (P>0.05). The glycated albumin in the observation group and control group were (21.38±5.74)% and (21.93±6.51)% at baseline; after 4 weeks of treatment, they were (20.08±6.05)% and (20.58±7.30)% (the changes from baseline in these two groups were (-1.19±4.37)% and (-1.20±5.08)%]; after 8 weeks of treatment, they were (19.07±5.56)% and (20.83±8.74)% [the changes from baseline were (-2.09±4.51)% and (-0.98±6.85)%]; after 12 weeks of treatment, they were (19.03±5.19)% and (19.36±6.14)% [the changes from baseline were (-2.18±4.60)% and (-2.47±5.20)%], there were no significant differences between two groups (P>0.05). The subgroup analysis showed that in those patients with the characteristics including body mass index (BMI)≥25 kg/m2 at baseline, the duration of diabetes mellitus longer than 8 years, fasting blood glucose less than 8 mmol/L and using insulin at baseline, the changes of HbA1c from baseline to the end of 12 weeks therapy in the observation group were more than in the control group. There were no significant differences between the two groups in terms of safety profiles, including the vital signs and laboratory findings (blood cell counts, liver function, and kidney function, all P>0.05). Conclusion Administration of BTVBT in T2DM patients for 12 weeks does not remarkably improve the HbA1c. Key words: Type 2 diabetes mellitus; Bifidobacterium tetragenous viable bacteria; Glycosylate hemoglobin A1c