Abstract:

Objective   To evaluate the efficacy and safety of recombinant human glucagon-like peptide-1(rhGLP-1) subcutaneously administered before meals in combination with oral metformin in patients with type 2 diabetes mellitus. Methods   In this randomized, double-blind and placebo-controlled study, 42 patients with type 2 diabetes were randomly divided into the study group and the control group, 21 patients in each group. They were subcutaneously administrated with 0.2mg of rhGLP-1(7-36)  or a placebo in addition to an original dose of metformin, and then they were followed for 12 weeks. The changes of glucose, HbA1c and other safety indexes from the baseline to the endpoint were observed. Results   The levels of HbA1c, and fasting and postprandial blood glucose were obviously reduced from the baseline to the study endpoint with the treatment of rhGLP-1, and those reductions were more significant than in the control group (P<0.05). The body mass index(BMI) was significantly reduced in both groups(P<0.05), while there was no difference between the two groups. The reduction of BMI was associated with the baseline in the study group(P>0.05). There was no definitive hypoglycemia in either group. The most common reported adverse events were gastrointestinal symptoms, which were usually mild to moderate and had spontaneous remission with time.Incidences of adverse events had no significant difference between the two groups(P>0.05).  Conclusion   Subcutaneous injection of rhGLP-1 in combination with oral metformin is effective in improving glucose control in patients with type 2 diabetes, without increasing adverse events.

Key words: Type 2 diabetes mellitus; Metformin; Recombinant human glucagon-like peptide-1; Efficacy; Safety