A Multicenter, Randomized, Open-Label Study to Compare the Effects of Gemigliptin Add-on or Escalation of Metformin Dose on Glycemic Control and Safety in Patients with Inadequately Controlled Type 2 Diabetes Mellitus Treated with Metformin and SGLT-2 Inhibitors (SO GOOD Study)

被引:0
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作者
Kim, Hae Jin [1 ]
Noh, Jung Hyun [2 ]
Moon, Min Kyong [3 ]
Choi, Sung Hee [4 ]
Ko, Seung-Hyun [5 ]
Rhee, Eun-Jung [6 ]
Hur, Kyu Yeon [7 ]
Jeong, In-Kyung [8 ]
机构
[1] Ajou Univ, Dept Endocrinol & Metab, Sch Med, Suwon, South Korea
[2] Inje Univ, Ilsan Paik Hosp, Dept Med, Div Endocrinol & Metab,Coll Med, Goyang, South Korea
[3] Seoul Natl Univ, Seoul Metropolitan Govt Seoul Natl Univ, Dept Internal Med, Div Endocrinol & Metab,Boramae Med Ctr,Coll Med, Seoul, South Korea
[4] Seoul Natl Univ, Coll Med, Dept Internal Med, Div Endocrinol & Metab,Bundang Hosp, Seoul, South Korea
[5] Catholic Univ Korea, St Vincents Hosp, Coll Med, Div Endocrinol & Metab,Dept Internal Med, Seoul, South Korea
[6] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Dept Endocrinol & Metab, Sch Med, Seoul, South Korea
[7] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Div Endocrinol & Metab,Sch Med, Seoul, South Korea
[8] Kyung Hee Univ, Hosp Gangdong, Dept Internal Med, Div Endocrinol & Metab,Sch Med, Seoul, South Korea
关键词
DIPEPTIDYL PEPTIDASE-4 INHIBITORS; GLUCOSE COTRANSPORTER 2; COMBINATION THERAPY; MANAGEMENT; EFFICACY; TRIAL; MONOTHERAPY; GLUCAGON; DRUG;
D O I
10.1155/2024/8915591
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
<bold>Background: </bold>We aimed to compare efficacy and safety between gemigliptin add-on and escalation of the metformin dose in patients with inadequately controlled type 2 diabetes mellitus (T2DM) despite treatment with metformin and SGLT2 inhibitors.<bold>Methods: </bold>This study was a multicenter, randomized, open-label, active-controlled, parallel-group comparative study. Patients with T2DM uncontrolled on metformin and SGLT2 inhibitors were randomized to receive gemigliptin 50 mg as an add-on (GEM group, n = 37) or escalation of the metformin dose (500 mg, MET group, n = 38) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to week 24.<bold>Results: </bold>At weeks 12 and 24, the reduction in HbA1c levels was significantly greater in the GEM group than in the MET group (GEM vs. MET = -0.64% +/- 0.34% vs. -0.36% +/- 0.50%, p = 0.009 at week 12; -0.61% +/- 0.35% vs. -0.33% +/- 0.70%, p = 0.045 at week 24). The proportions of patients who achieved target HbA1c levels of <7.0% at weeks 12 and 24 and <6.5% at week 12 were greater in the GEM group than in the MET group. An index of beta-cell function was also significantly improved in the GEM group. The safety profiles were similar between the two groups.<bold>Conclusions: </bold>Gemigliptin add-on therapy may be more effective than metformin dose escalation in patients with T2DM insufficiently controlled using metformin and SGLT2 inhibitors, without safety concerns. This trial is registered with CRIS_number: KCT0003520.
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页数:10
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