Table 1.
Characteristics of Patients in the Randomised Controlled Trials Evaluated in this Meta-Analysis on the Use of Gemigliptin in Type 2 Diabetes Mellitus
| Study | No. of patients in gemigliptin & control groups | Patient characteristics and nature of controls | Duration of study, wk | Outcomes evaluated in the study |
|---|---|---|---|---|
| Ahn et al. (2017) [15] | Gemigliptin 50 mg/day (n=107); placebo (n=109) | Korean patients inadequately controlled with metformin and glimepiride Mean age 61.4 years (gemigliptin), 60.4 years (placebo) Baseline HbA1c 8.2% in both groups |
24 | Mean change in HbA1c from baseline to week 24 The change in HbA1c was significantly greater in the gemigliptin group (−0.88%) than in the placebo group (−0.01%) |
| Bae et al. (2019) [20] | Group 1: gemigliptin (50 mg)/rosuvastatin (20 mg) (n=96) Group 2: gemigliptin (50 mg) (n=97) Group 3: rosuvastatin (20 mg) (n=97) |
Patients with T2DM and dyslipidaemia on metformin for at least 6 weeks Mean age (years) 55.5, 56.1, 56.2 Baseline HbA1c 7.79%, 7.79%, 7.78% Baseline LDL-C (mg/dL) 133.4, 142.0, 133.6 in Groups 1, 2, 3, respectively |
24 | Changes in HbA1c and LDL-C from baseline to week 24 between Groups 1, 3 and between Groups 1, 2, respectively Change in HbA1c was significantly greater in Group 1 (−0.54%) than in Group 3 (−0.27%) Change in LDL-C was significantly greater in Group 1 (−53 mg/dL) than in Group 2 (−1.1 mg/dL) |
| Cho et al. (2020) [16] | Gemigliptin 50 mg/day (n=188); placebo (n=95) | Patients with T2DM, on background therapy with insulin or insulin plus metformin Mean age 61.1 years (gemigliptin), 59 years (placebo) Baseline HbA1c 8.4% in both groups |
24 | Mean change in HbA1c from baseline to week 24 The mean change in HbA1c was significantly greater in the gemigliptin group (−0.7%) than in the dapagliflozin group (−0.1%) |
| Kwak et al. (2020) [11] | Gemigliptin 50 mg/day (n=35); dapagliflozin 10 mg/day (n=36) | Patients with T2DM, who were either drug-naïve or uncontrolled with metformin Mean age 61.1 years (gemigliptin), 59 years (dapagliflozin) Baseline HbA1c 7.9% in both groups Use of metformin: n=17 (gemigliptin), n=23 (dapagliflozin) |
12 | Change in MAGE after 12 weeks compared to baseline The change in MAGE was significantly greater in the gemigliptin group (−27.2 mg/dL), than in the dapagliflozin group (−7.9 mg/dL). |
| Lim et al. (2017) [12] | Group 1: gemigliptin 50 mg/day+metformin 1,000–2,000 mg/day (n=136) Group 2: gemigliptin 50 mg/day (n=140) Group 3: metformin 1,000–2,000 mg/day (n=148) |
Patients with T2DM, who were either drug-naïve or on single OAD after a 8-week washout Mean age (years) 54.4, 53.4, 54 Baseline HbA1c 8.6%, 8.6%, 8.7% in Groups 1,2, 3, respectively |
24 | Mean change in HbA1c from baseline to week 24 The mean change in HbA1c was significantly greater in Group 1 (−2%), than in Group 2 (−1.24%) and Group 3 (−1.47%) |
| Park et al. (2017) [14]a | Gemigliptin 50 mg/day (n=24); sitagliptin 100 mg/day (n=21) | Patients with T2DM, who were either drug-naïve or on OADs for <8 weeks Mean age 50 years (gemigliptin), 50 years (sitagliptin) Baseline HbA1c 9.5% (gemigliptin), 9.1% (sitagliptin) |
12 | Mean change in MAGE at week 12 compared with baseline The mean change in MAGE was comparable between the gemigliptin group and the sitagliptin group (−42 mg/dL in both groups) |
| Park et al. (2017) [14]b | Gemigliptin 50 mg/day (n=24); glimepiride 2 mg/day (n=21) | Patients with T2DM, who were either drug-naïve or on OADs for <8 weeks Mean age 50 years (gemigliptin), 50 years (glimepiride) Baseline HbA1c 9.5% (gemigliptin), 9.7% (glimepiride) |
12 | Mean change in MAGE at week 12 compared with baseline The mean change in MAGE was significantly greater in the gemigliptin group (−42 mg/dL) than in the glimepiride group (−21 mg/dL) |
| Study | No. of patients in gemigliptin & control groups |
Patient characteristics and nature of controls |
Duration of study, wk | Outcomes evaluated in the study |
| Rhee et al. (2010) [17] | Group 1: gemigliptin 50 mg/day (n=35) Group 2: gemigliptin 100 mg/day (n=37) Group 3: gemigliptin 200 mg/day (n=35) Placebo (n=34) |
Patients with T2DM, who were drug-naïve Mean age (years) 52.4, 53.2, 54.2, 51.2 Baseline HbA1c 8.24%, 8.18%, 8.16%, 8.2% in Groups 1, 2, 3, 4 respectively |
12 | Mean change in HbA1c from baseline to week 12 The mean change in HbA1c was greater in Group 1 (−0.98%) than in Groups 2, 3, 4 (−0.74%, −0.78%, and −0.06%, respectively) |
| Rhee et al. (2013) [13] | Group 1: gemigliptin 25 mg/day (n=46) Group 2: gemigliptin 50 mg/day (n=49) Group 3: sitagliptin 100 mg/day (n=42) (added to metformin) |
Patients with T2DM on metformin monotherapy for at least 12 weeks Age 18–75 years Baseline HbA1c 8%, 7.9%, 8% in Groups 1, 2, 3, respectively |
24 | Mean change in HbA1c from baseline to week 24 The mean change in HbA1c was comparable between Group 2 (−0.77%) and Group 3 (−0.8%) |
| Yang et al. (2013) [18] | Gemigliptin 50 mg/day (n=107); placebo (n=109) | Patients with T2DM not on any OADs for at least 6 weeks Mean age 54 years (gemigliptin), 52 years (placebo) Baseline HbA1c 8.2% (gemigliptin), 8.3% (placebo) |
24 | Mean change in HbA1c from baseline to week 24 The mean change in HbA1c was significantly greater in the gemigliptin group than in the placebo group (adjusted mean after subtracting the placebo effect size, −0.71%) |
| Yoon et al. (2017) [19] | Gemigliptin 50 mg/day (n=64); placebo (n=66) | Patients with T2DM, either treatment naïve or on insulin or sulphonylurea, with moderate to severe renal impairment Mean age 61.7 years (gemigliptin), 62.3 years (placebo) Baseline HbA1c 8.3% (gemigliptin), 8.4% (placebo) eGFR (mL/min/1.73 m2) 31.2 (placebo), 35.4 (gemigliptin) |
12 | Mean change in HbA1c from baseline to week 12 The mean change in HbA1c was significantly greater in the gemigliptin group (−0.82%) than in the placebo group (0.38%) |
HbA1c, haemoglobin A1c; T2DM, type 2 diabetes mellitus; LDL-C, low-density lipoprotein cholesterol; MAGE, mean average glucose excursion; OAD, oral anti-diabetes medication; eGFR, estimated glomerular filtration rate.