Efficacy and safety of gemigliptin as add‐on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study)

Cho, Young Min; Deerochanawong, Chaicharn; Seekaew, Samroeng; Suraamornkul, Swangjit; Benjachareonwong, Sunun; Sattanon, Sarinya; Chamnan, Parinya; Sirirak, Thanitha; Kosachunhanun, Natapong; Pratipanawatr, Thongchai; Suwanwalaikorn, Sompongse; Lee, Woo Je; Kim, Sung‐Rae; Choi, Seonghui; Kang, Eun Seok; Oh, Tae Jung; Kwon, Sam Hyun; Lee, Moon Kyu

doi:10.1111/dom.13873

Cited by 9 publications

(11 citation statements)

References 13 publications

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“…1). Ten RCTs in people with T2DM that fulfilled all the inclusion criteria were analysed in this meta-analysis [11][12][13][14][15][16][17][18][19][20]. Thirteen studies were excluded as they either evaluated the pharmacokinetic and pharmacodynamic properties of gemigliptin, did not have a valid control group, or were observational extensions of RCTs.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2021

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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; I 2 =0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, −0.91%; 95% CI, −1.18 to −0.63); P <0.01; I 2 =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; I 2 =74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P <0.01; I 2 =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; I 2 =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; I 2 =35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P =0.61; I 2 =19%; HCE). Conclusion Gemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.

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Section: Resultsmentioning

confidence: 99%

“…The remaining six studies, which included placebos or any other medications without blood glucose-lowering properties in the control group (e.g., anti-lipid medications) were analysed as the PCG. The PCG included the studies by Ahn et al [15], Cho et al [16], Rhee et al…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2021

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“…Gemigliptin is a DPP-4 inhibitor developed by LG Chem (Seoul, Korea), which was marketed after approval by the Ministry of Food and Drug Safety in the Republic of Korea in 2012, and its efficacy and safety have been confirmed in various clinical studies [16][17][18][19][20][21]. This study aimed to evaluate and compare the efficacy and safety of gemigliptin 50 mg as an add-on therapy with placebo in patients with T2DM who had inadequate glycemic control with metformin and dapagliflozin.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION)

Lee¹,

Min²,

Hong³

et al. 2023

Endocrinol Metab

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Background: This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin.Methods: In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (<i>n</i>=159) or placebo (<i>n</i>=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks.Results: The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was –0.66% (0.07) with a 95% confidence interval of –0.80% to –0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted.Conclusion: Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.

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“…Due to these advantages, various randomized controlled trials (RCTs) have been performed in phases II and III prior to market release, and the results have been encouraging as compared to those of its counterparts. Comparative trials have been conducted for gemigliptin and placebo in patients with type 2 diabetes 10 – 15 . Also, comparative trials with oral anti-diabetic drugs (OADs), such as sitagliptin, glimepiride, metformin, linagliptin, and dapagliflozin, have been conducted in several countries 13 , 16 – 20 .…”

Section: Introductionmentioning

confidence: 99%

Antidiabetic effect of gemigliptin: a systematic review and meta-analysis of randomized controlled trials with Bayesian inference through a quality management system

Nguyen

Yoon

et al. 2021

Sci Rep

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Gemigliptin is one of the latest dipeptidyl peptidase-4 inhibitors developed by LG Life Sciences. Since the early 2000s, several randomized controlled trials (RCTs) of gemigliptin have been conducted. However, no study has directly compared its antidiabetic effects through a systematic review and meta-analysis. Therefore, in this study, we performed a systematic review and meta-analysis on RCTs. In particular, a subsequent meta-analysis was performed using Bayesian inference, and an updated quality management system model was integrated throughout our study. The mean differences and 95% confidence intervals for glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), homeostatic model assessment beta cell function (HOMA-β), and low-density lipoprotein (LDL) were evaluated for the efficacy outcomes of gemigliptin as compared to those of placebo and other oral antidiabetic drugs (OADs). In conclusion, we found that gemigliptin was superior to placebo and comparable to other OADs in terms of the effect on HbA1c, FPG, HOMA-β, and LDL. Further, gemigliptin was more effective than other OADs in HbA1c and HOMA-β in Bayesian inference analysis and statistically significant to other OADs in HbA1c and HOMA-β in sensitivity analysis excluding metformin. However, to confirm the results, more studies need to be analysed and the minimum clinically important difference must be applied.

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Efficacy and safety of gemigliptin as add‐on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study)

Cited by 9 publications

References 13 publications

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

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

Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION)

Antidiabetic effect of gemigliptin: a systematic review and meta-analysis of randomized controlled trials with Bayesian inference through a quality management system

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