Teneligliptin a safe and effective treatment option for T2DM
In patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise, teneligliptin presents a safe and effective way of disease control, a recent study has found.
The researchers conducted a multicentre, randomized, double-blind trial on T2DM patients, who were given either 20 g of oral teneligliptin (n=125; mean age, 52.1±10.2 years) or placebo (n=127; mean age, 56.0±10.2 years). The primary efficacy endpoint was the change in glycosylated haemoglobin (HbA1c) levels over 24 weeks of observation. Safety was evaluated according to adverse side-effects and drug reactions.
Patients who received the test medication showed a least square mean (LSM) HbA1c change of –0.95±0.06 percent over the 24-week study period. The corresponding change in the placebo group was –0.14±0.06 percent, leading to a significant between-group difference of –0.80±0.09 percent (p<0.0001).
In terms of safety, the researchers documented adverse events (AEs) in 76.4 percent of the teneligliptin group and 71.7 percent of the placebo group. Common side effects included infections and infestations, respiratory tract infections, and metabolism and nutrition disorders. There were six serious AEs in the teneligliptin group and five in the placebo group; no deaths were reported.
Teneligliptin was also superior to placebo in terms of secondary outcomes, including the 24-week change in fasting plasma glucose and the percentage of patients with HbA1c ≥7.0 percent.
Important study limitations included the lack of an active comparator and the relatively short duration of follow-up. Future studies should work to address these in order to better show the efficacy of teneligliptin in T2DM patients.