A 52‐week extension study of switching from gemigliptin vs sitagliptin to gemigliptin only as add‐on therapy for patients with type 2 diabetes who are inadequately controlled with metformin alone

Abstract

We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,-0.99% [95% CI -1.25%, -0.73%]; G1/G2, -1.11% [95% CI -1.33%, -0.89%]; G2/G2, -1.06% [95% CI -1.28%, -0.85%]). The percentage of patients achieving HbA1c < 6.5% was 27.6% in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3% to 32.7% in the G2/G2 group (difference in proportions, 5% [95% CI -6%, 17%]), while it increased from 6.8% to 27.3% from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20% [95% CI 7%, 34%]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.

Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis

“…The details of the studies included in this meta-analysis are shown in Table 1. The studies that were evaluated but excluded are summarized in Table 2 [15,[20][21][22][23]. The study by Han et al [21] was excluded as it was an open observational extension of an RCT wherein the placebo was replaced with linagliptin.…”

Real World Study of Effectiveness of Gemigliptin Add-On Therapy in Type 2 Diabetes Mellitus

“…There was no increased risk of adverse effects with gemigliptin compared with sitagliptin [10]. This study was extended by 28 weeks in which patients who had been treated with sitagliptin were switched over to gemigliptin, and so all T2DM subjects received 50 mg gemigliptin daily for 28 weeks [11]. HbA1c reduction from baseline was −1.06 in subjects who continued to receive gemigliptin while an additional 0.1% hba1c reduction from baseline was noted in patients who were switched from sitagliptin to gemigliptin [11].…”

Comparison of the effects of gemigliptin versus glimepiride on cardiac function in patients with type 2 diabetes uncontrolled with metformin: The gemi‐heart study

“…Although some studies have suggested positive effects of DPP‐4 inhibitors, these studies had small sample sizes, and the risks and benefits of DPP‐4 inhibitors in terms of CVD remain unclear 9,10 . Clinical studies have shown that gemigliptin, a novel DPP‐4 inhibitor, has glucose‐lowering efficacy similar to that of sitagliptin or linagliptin 11,12 . However, studies of its effect on cardiovascular safety are lacking.…”

“…9,10 Clinical studies have shown that gemigliptin, a novel DPP-4 inhibitor, has glucose-lowering efficacy similar to that of sitagliptin or linagliptin. 11,12 However, studies of its effect on cardiovascular safety are lacking. Considering the increased risk of hospitalizations in patients with HF reported in some studies of DPP-4 inhibitors, any direct effects of gemigliptin on cardiac function would be clinically important.…”