Can teneligliptin be safely and effectively given to patients with inadequately controlled type 2 diabetes by triple oral antidiabetic drug treatment?

This study compared the effectiveness and safety of teneligliptin (Tenelia) to placebo in patients with type 2 diabetes (T2D) that was inadequately controlled with triple oral antidiabetic drugs (OADs). The study showed that teneligliptin may be considered as a fourth add-on OAD treatment in these patients.

T2D is frequently linked to a lack of insulin production (insulin deficiency) or an inability to respond to insulin (insulin resistance). However, new evidence suggests that the gut-derived hormone incretin which stimulates insulin secretion, and kidney regulation of sodium and glucose, may also be important.

Although new OADs are available that can be combined, some patients are still unable to achieve their blood glucose targets. While more intensive, injectable medication is useful, practical limitations for patients that are elderly emphasize the need to investigate possible add-on OAD treatments.

Triple OAD treatment consists of metformin (Glucophage), sulphonylurea (SU) medications such as glimepiride (Amaryl), and a sodium-glucose co-transporter-2 (SGLT-2) inhibitor such as canagliflozin (Invokana). Teneligliptin is a type of oral, antidiabetic drug commonly known as a gliptin. It improves blood glucose levels by slowing the breakdown of incretin and increasing insulin. The effectiveness and safety of teneligliptin as a fourth therapeutic option are unclear.

This study included 100 patients with T2D on triple OADs. Patients had failed to achieve their blood glucose targets after treatment with triple OADs for more than 12 weeks. 51 patients were randomly assigned to a teneligliptin group (group 1) and 49 patients to a placebo group (group 2). Patients in the teneligliptin group received 20 mg of the drug once daily for 24 weeks. Placebo was given once daily for 12 weeks, followed by a switch to 20 mg of teneligliptin once daily for the remaining 12 weeks.

The average HbA1c (a marker of blood glucose control for the past 2-3 months) level at the beginning of the study was 7.8%. A change in HbA1c levels was evaluated at 12 and 24 weeks.

At 12 weeks, a significant reduction in HbA1c from baseline occurred in the teneligliptin group (by 0.9%), compared to the placebo group (by 0.2%). At 24 weeks, significant reductions in HbA1c levels occurred in both groups. There were no significant differences in the occurrence of side effects between the groups. Both groups had favorable safety profiles.

The study indicated that teneligliptin may be added as a fourth drug for patients that failed to achieve their HbA1c targets with triple OADs.  

The study had a short follow-up period. Longer-term studies are needed. The study was done on Korean patients and did not account for possible genetic and lifestyle differences.