Key result
Gemigliptin significantly reduced HbA1c by 0.91% compared to passive controls at 24 weeks, and demonstrated comparable glycemic efficacy to active controls.
Why the study?
Does gemigliptin improve HbA1c in patients with type 2 diabetes?
Meta-Analysis (n=1,792)
Does gemigliptin improve HbA1c in patients with type 2 diabetes?
Mean Difference: -0.91 (95% CI -1.18–-0.63)
p-value: p=<0.01
Gemigliptin provides effective glycaemic control comparable to active comparators and superior to placebo over 6 months, with a favorable safety profile.
Supports gemigliptin for glycemic control in type 2 diabetes; confirms efficacy versus placebo with comparability to active agents.
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; P=0.24; I2=0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, -0.91%; 95% CI, -1.18 to -0.63); P<0.01; I2=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; P=0.02; I2=74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P<0.01; I2=69%; HCE). Gemigliptin was comparable to ACG regarding achieving HbA1c <7% after 24 weeks (OR, 0.92; 95% CI, 0.52 to 1.63; P=0.77; I2=66%; MCE). Adverse events were similar between the gemigliptin and control groups (risk ratio [RR], 1.06; 95% CI, 0.82 to 1.36; P=0.66; I2=35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P=0.61; I2=19%; HCE). CONCLUSION: Gemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.
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Dutta et al. (2021) conducted a meta-analysis in Type 2 Diabetes (n=1,792). Gemigliptin vs. Passive control (placebo/rosuvastatin) or active control (metformin/dapagliflozin/sitagliptin/glimepiride) was evaluated on Change in haemoglobin A1c (HbA1c) at 24 weeks compared to passive control group (MD -0.91%, 95% CI -1.18 to -0.63, p=<0.01). Gemigliptin significantly reduced HbA1c by 0.91% compared to passive controls at 24 weeks, and demonstrated comparable glycemic efficacy to active controls.
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