ABSTRACT
Objective:To compare the efficacy and safety of Tonghua Dongbao′s insulin aspart injection (Rishulin) and NovoRapid (Novo Nordisk) in the treatment of diabetes.Methods:A 26-week, randomized, open-label, parallel-group, positive control drug and non-inferiority trial was conducted in 23 centers in China. A total of 563 diabetes with poor blood glucose control treated with insulin for at least 3 months before were included. The subjects were randomized(stratified block random method) into those receiving Rishulin or NovoRapid at a ratio of 3∶1. Both groups were combined with basal insulin (Lantus). The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to the end of 24 weeks of treatment.Results:For full analysis set, after 24 weeks of treatment, HbA1c level of Ruishulin group decreased from (8.66±1.28)% to (7.77±1.09)% ( P<0.001), and that of NovoRapid group decreased from (8.47±1.28) % to (7.65±0.97) % ( P<0.001). Treatment difference in HbA1c (NovoRapid group-Ruishulin group) was -0.061% (95% CI -0.320-0.199). HbA1c<7.0% target reacing rates were 24.26% and 21.21% ( P=0.456), and HbA1c<6.5% target reacing rates were 9.65% and 6.82% ( P=0.310) in Ruishulin group and NovoRapid group, repectively. The standard 2 hours postprandial blood glucose (2hPG) in Ruishulin group decreased from (16.23±5.22) mmol/L to (12.65±4.57) mmol/L ( P<0.001), and 2hPG in NovoRapid group decreased from (16.13±5.37) mmol/L to (11.91)±4.21) mmol/L ( P<0.001). The fingertips blood glucose at 7-point of both groups exhibited varying degrees of reduction compared with those at baseline, repectively. Positive ratios of specific antibodies were 31.68% in Ruishulin group and 36.36% in NovoRapid group ( P=0.320). Ratios of negative to positive were 7.43% and 10.61% ( P=0.360), and ratios of positive to negative were 10.40% and 7.58% ( P=0.360) in Ruishulin group and NovoRapid group, respectively. The incidence of hypoglycemia was 60.05% and 55.40% ( P=0.371), and the incidence of adverse events was 76.60% and 77.70% ( P=0.818) in Ruishulin group and NovoRapid group, respectively. Conclusions:Rishulin is not inferior to NovoRapid, and has shown good efficacy and safety. It can be an ideal choice for clinicians in patients with poor blood glucose control with insulin.
ABSTRACT
Objective To investigate the relationships of serum level of retinol binding protein (RBP)and adiponectin(APN)with renal injury in elderly patients with diabetic nephropathy(DN).Methods A total of 50 patients with DN in our hospital from June 2016 to June 2018 were recruited in the retrospective study.According to the level of 24-hour urinary albumin excretion rate(UAER),the patients were divided into the low-level group(30-300 mg/d,n=30,)and the medium-level group(＞300 mg/d,n=20,).During the same period,50 patients with simple diabetes mellitus (DM)and 50 healthy persons were recruited as the DM group and the control group.Serum RBP and APN levels were determined in all groups.The relationships of APN and RBP level with 24-h UAER were analyzed by Pearson correlation analysis.Results Serum APN level(mg/L)was lower in DN(4.6± 0.9)patients than in DM(14.2±1.2)and in control groups(14.6±1.2) (P＜0.01).The serum levels of RBP(mg/L) was higher in DN patients(98.1 ± 10.2) than in DM (38.3 ± 3.5) and in control groups (37.1±3.2)(P＜0.05).The 24-h UAER was higher in DN patients(300.1±30.2)than in DM(13.1 ± 1.2) and in control groups(12.3 ± 1.5) (P ＜ 0.05).There was no significant difference in levels of serum RBP and APN and 24-hour UAER between the DM and control groups(P ＞ 0.05).Pearson correlation analysis showed that serum APN level was negatively correlated with 24-h UAER,and serum RBP level was positively correlated with 24-h UAER(r =-0.723 and 0.711,P＜0.01).Serum APN level was lower and serum RBP level was higher in medium-level group than in low-level group [(3.1±0.2) mg/L vs.(5.2±0.5) mg/L,(102.3±10.6) mg/L vs.(75.6±7.2) mg/L,t =21.829 and 10.661,respectively,all P＜0.01].Conclusions Serum RBP is positively related to,and APN level is negatively related to the occurrence and development of DN in elderly patients.Serum RBP and APN can be used as important indicators for evaluating renal injury in elderly patients.