A comparison of effects between recombinant insulin lispro and insulin lispro in treating type 2 diabetes mellitus
10.3969/j.issn.1671-8348.2016.18.022
- VernacularTitle:重组赖脯胰岛素与赖脯胰岛素治疗T2DM的疗效比较
- Author:
Xuxia QIAO
;
Cheng XU
- Publication Type:Journal Article
- Keywords:
diabetes mellitus,type 2;
recombinant insulin lispro;
treatment outcome;
safety
- From:
Chongqing Medicine
2016;45(18):2518-2521
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the efficacy and safety of recombinant insulin lispro and insulin lispro in the treatment of type 2 diabetes mellitus(T2DM ) .Methods Forty‐eight T2DM patients with poor blood glucose control were randomly assigned to the recombinant insulin lispro group (observation group ,n=32) and insulin lispro group (control group ,n=16) according to the ratio of 2∶1 .On the basis of injection of the recombinant insulin glargine once daily before sleep ,the two groups were given the re‐combinant insulin lispro injection or insulin lispro injection once before each meal .The period of treatment was 16 weeks .The levels of HbA1c ,2 h postprandial blood glucose(2hPG) and fasting plasma glucose(FPG) before and after treatment were measured and compared between the two groups .The adverse events were evaluated at the end of treatment .Results Forty‐four cases finished the study ,28 cases in the observation group and 16 cases in the control group .The levels of HbA1c ,FPG and 2hPG after 16‐week treatment in the two groups were decreased significantly (P<0 .05) .The decrease amplitudes of HbA1c in the observation group and the control group were (1 .55 ± 1 .50)% and(1 .06 ± 1 .30)% respectively ,which of FPG were (2 .07 ± 5 .01)mmol/L and (1 .09 ± 3 .18)mmol/L respectively ,and which of 2hPG declined (3 .28 ± 5 .71)mmol/L and(3 .60 ± 5 .89)mmol/L respectively . With HbA1c as the main evaluation index and 0 .40 as the non‐inferiority critical value ,non‐inferiority was found in the recombi‐nant insulin lispro injection as compared with the insulin lispro injection (P<0 .05) .The standard‐reaching rate of HbA1c less than 6 .50% in observation group was 14 .29% ,and which of HbA1c less than 7 .00% was 28 .57% ;in control group ,these two stand‐ard‐reaching rates were 18 .75% and 43 .75% respectively ,and there were no statistically significant differences between two groups (P>0 .05) .Conclusion The recombinant insulin lispro injection has non‐inferiority effects in the aspect of effectiveness compared with the lispro insulin injection ,moreover they have the same safety .
