Objective         To assess the efficacy and safety of linagliptin combined with insulin lispro50/50 in newly diagnosed type-2 diabetes mellitus (T2DM) patients.       Methods      A total of 131 outpatients with newly diagnosed T2DM from January to July in 2015 was enrolled from Xinqiao hospital. After follow-up

the patients were divided into the observation group and the control group

with 61 patients in each group. There were 66 males and 56 females at an average age of 44.6±11.3 years old. The observation group was administered with linagliptin combined with insulin lispro50/50

while the control group was given with single insulin lispro50/50 for 12 weeks. The fasting plasma glucose (FPG)

2-hour postprandial plasma glucose (2hPG)

hemoglobin Alc (HbAlc)

body mass index (BMI)

daily insulin dosage

insulin resistance index (HOMAIR)

and the incidence of hypoglycemia in the both groups were observed.       Results       After 12 weeks

the levels of FPG

2hPG and HbAlc were decreased in both groups (P0.05). FPG

2hPG and HbA1c of the observation group and the control group were 6.8±0.6 and 6.6±1.0 mmol/L

8.9±1.2 and 8.5±1.4 mmol/L

and (6.9±1.0)% and (6.7±0.8)%

respectively. There were significant decreases in the above indexes

but no statistical differences were observed in the decrease amplitudes between the 2 groups (P0.05). There was no significant difference in BMI (P0.05). Daily insulin dosage and HOMAIR were reduced to 15.1±2.2 U and 3.0±0.2

respectively

in the observation group

and it showed a significant difference compared with the baseline level (P0.05). During the followup

the hypoglycemia incidences in the observation group and the control group were 9 cases and 12 cases

respectively

with statistically significant difference (P0.05).        Conclusion      Compared with the insulin lispro50/50 alone

linagliptin combined with insulin lispro50/50 can significantly decrease the levels of daily insulin dosage and HOMA-IR

and lower the incidence of hypoglycemia.