Adverse events
gastrointestinal reactions, hyperpigmentation, nausea and vomiting, vomiting, pruritus, digestive problems
INDURATION, ADVERSE EVENT, HYPERPIGMENTATION, SUBCUTANEOUS NODULES
The most frequently reported side effects in the MET group were gastrointestinal reactions such as diarrhea(8/32), nausea(13/32), vomiting (2/32), and abdominal distension (10/32) which usually occurred in the first 4 weeks of therapy. Most side effects were gradually resolved from the 8th to12th week. In the COMB group, subcutaneous induration with a diameter of less than 1.0cm at the injection site was most commonly documented with an incidence of 46%(15/32) in the first month after the start of beinaglutide injection, accompanied with intermittent itching. 13 patients reported the subcutaneous nodules faded to complete disappearance after about one month, while 2 patients still had about 2 mm of hyperpigmentation on the abdomen at the end of the follow-up period. The second most common was pruritus locally at the injection site with an incidence of 40%(13/32). In the first 4 weeks of COMB treatment,10/32 individuals had slight digestive problems (nausea and vomiting). However, there was no statistical difference in the incidence of gastrointestinal side effects between the two groups(both P>0.05, Adverse events inclusive of ITT.Data are presented as n/N (%). COMB, combination of metformin and beinaglutide; MET, Metformin. ITT, intention-to-treat analysis.