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.