Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis
Deep Dutta, Anshita Aggarwal, Indira Maisnam, Rajiv Singla, Deepak Khandelwal, Meha Sharma
Abstract
Background: No meta-analysis has holistically analysed and summarised the efficacy and safety of gemigliptin in type 2 diabetes. The meta-analysis addresses this knowledge gap.Methods: Electronic databases were searched for randomised controlled trials (RCTs) involving diabetes patients receiving gemigliptin in the intervention arm and placebo/active comparator in the control arm. The primary outcome was change in haemoglobin A1c (HbA1c). The secondary outcomes were alterations in glucose, glycaemic targets, lipids, insulin resistance, and adverse events.Results: Data from 10 RCTs involving 1,792 patients were analysed. Four had an active control group (ACG), with metformin/dapagliflozin/sitagliptin/glimepiride as the active comparator; six had a passive control group (PCG), with placebo/rosuvastatin as controls. HbA1c reduction by gemigliptin at 24 weeks was comparable to ACG (mean difference [MD], 0.09%; 95% confidence interval [CI], –0.06 to 0.23; <i>P</i>=0.24; <i>I<sup>2</sup></i>=0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, –0.91%; 95% CI, –1.18 to –0.63); P<0.01; <i>I<sup>2</sup></i>=89%; high certainty of evidence [HCE]). Gemigliptin was superior to PCG regarding achieving HbA1c <7% (12 weeks: odds ratio [OR], 5.91; 95% CI, 1.34 to 26.08; <i>P</i>=0.02; <i>I<sup>2</sup></i>=74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P<0.01; <i>I<sup>2</sup></i>=69%; HCE). Gemigliptin was comparable to ACG regarding achieving HbA1c <7% after 24 weeks (OR, 0.92; 95% CI, 0.52 to 1.63; <i>P</i>=0.77; <i>I<sup>2</sup></i>=66%; MCE). Adverse events were similar between the gemigliptin and control groups (risk ratio [RR], 1.06; 95% CI, 0.82 to 1.36; <i>P</i>=0.66; <i>I<sup>2</sup></i>=35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; <i>P</i>=0.61; <i>I<sup>2</sup></i>=19%; HCE).Conclusion: Gemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.