Endocrinol Metab.  2021 Apr;36(2):374-387. 10.3803/EnM.2020.818.

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

Affiliations
  • 1Department of Endocrinology, Center for Endocrinology, Diabetes, Arthritis & Rheumatism (CEDAR) Superspeciality Clinics, New Delhi, India
  • 2Department of Endocrinology, Dr Ram Manohar Lohia (RML) Hospital, New Delhi, India
  • 3Department of Endocrinology, R G Kar Medical College, Calcutta, India
  • 4Department of Endocrinology, Kalpavriksh Healthcare, Dwarka, India
  • 5Department of Endocrinology, Maharaja Agrasen Hospital, New Delhi, India
  • 6Department of Rheumatology, Center for Endocrinology, Diabetes, Arthritis & Rheumatism (CEDAR) Superspeciality Clinics, New Delhi, India

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; 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.

Keyword

Glycated hemoglobin; Meta-analysis; Safety; Diabetes mellitus; type 2; Humans

Figure

  • Fig. 1 Flowchart of study retrieval and inclusion in the meta-analysis. RCT, randomized controlled trial.

  • Fig. 2 Risk of bias graph presenting the review authors’ judgements about each risk of bias item shown as percentages across all included studies.

  • Fig. 3 Risk of bias summary presenting the review authors’ judgements about each risk of bias item for each included study.

  • Fig. 4 Forest plot highlighting the impact of gemigliptin as compared to the active control group after 24 weeks of therapy on (A) haemoglobin A1c (HbA1c), (B) fasting glucose, (C) the percent of people achieving HbA1c <7%, (D) the percent of people achieving HbA1c less than 6.5%. SD, standard deviation; IV, inverse variance; CI, confidence interval; M-H, Mantel-Haenszel.

  • Fig. 5 Forest plot highlighting the impact of gemigliptin as compared to the passive control group after 24 weeks of therapy on (A) haemoglobin A1c (HbA1c), (B) fasting glucose, (C) the percent of people achieving HbA1c <7%, (D) the percent of people achieving HbA1c less than 6.5%. SD, standard deviation; IV, inverse variance; CI, confidence interval; M-H, Mantel-Haenszel.

  • Fig. 6 Forest plot highlighting the side effect profile of the use of gemigliptin as compared to controls focussing on (A) total adverse events, (B) severe adverse events, (C) total hypoglycaemic episodes, (D) death. M-H, Mantel-Haenszel; CI, confidence interval.


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Lakshmi Nagendra, Deep Dutta, Harish Bukkasagar Girijashankar, Deepak Khandelwal, Tejal Lathia, Meha Sharma
Ann Pediatr Endocrinol Metab. 2024;29(2):82-89.    doi: 10.6065/apem.2346162.081.


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