Table 2.
Study | No. of patients in gemigliptin and control groups | Patient characteristics and nature of controls | Duration of study, wk | Outcomes evaluated in the study and reasons for exclusion |
---|---|---|---|---|
Jung et al. (2018) [22] | Gemigliptin 25 mg twice daily switched to 50 mg once daily: G1/G2 (n=118), gemigliptin 50 mg continued at the same dose: G2/G2 (n=111), sitagliptin 100 mg switched to gemigliptin 50 mg: S/G2 (n=106) | Baseline HbA1c 8.1%, 7.9%, 7.6%, respectively in Groups G1/G2, G2/G2, S/G2 | 52 | Mean change in HbA1c from baseline to week 52 Excluded as it was not a RCT |
Han et al. (2018) [21] | Gemigliptin (n=66), placebo (n=66) After 12 weeks, gemigliptin group continued to receive gemigliptin (n=50), and placebo switched to linagliptin (n=52). |
Patients with T2DM, with moderate to severe renal impairment Mean age 62.6 years (gemigliptin), 62.1 years (linagliptin) Baseline HbA1c 8.4% in both groups eGFR (mL/min/1.73 m2) 36.1 (gemigliptin), 32.2 (linagliptin) |
52 | Mean change in HbA1c from baseline to week 52 Excluded as it was an open-label, 52-week extension study |
Ahn et al. (2017) [15] | Gemigliptin (n=5), placebo (n=5) | Patients with T2DM inadequately controlled with OADs and/or lifestyle modification Median age 56.5 years Median HbA1c 7.2% |
4 | Difference in peak lipopolysaccharide levels after high-fat meal tolerance test Excluded as it was a short RCT with a primary outcome related to lipopolysaccharide levels |
Cha et al. (2017) [23] | Gemigliptin (n=69), linagliptin (n=55), SGLT2 inhibitor (n=60) | Patients with T2DM who were receiving a DPP4 inhibitor or SGLT2 inhibitor as add-on therapy to metformin and/or a sulfonylurea Mean age (DPP4 inhibitors) 53.4 years (SGLT-2 inhibitors) 52.6 years Mean HbA1c (DPP4 inhibitors) 8.6% (SGLT-2 inhibitors) 8.3% |
24 | Difference in lipid profile between baseline and 24 weeks Excluded as it was a observational study on difference in lipid levels |
Bae et al. (2019) [20] | Gemigliptin (n=84) | Patients with T2DM who were prescribed gemigliptin for more than 180 days after renal/hepatic transplantation Mean age 58.3 years Mean HbA1c 8.16% |
24 | Change in HbA1c after 6 months, and safety associated with immunosuppressive treatment Excluded as it was a single-arm retrospective study |
HbA1c, haemoglobin A1c; RCT, randomised controlled trial; T2DM, type 2 diabetes mellitus; eGFR, estimated glomerular filtration rate; OAD, oral anti-diabetes medication; DPP4, dipeptidyl peptidase-4; SGLT-2, sodium glucose co-transporter 2.