Diabetes Obes Metab. 2026;28(3):2027-2037.

Efficacy and safety of combining empagliflozin in people with type 2 diabetes mellitus uncontrolled with metformin and sitagliptin: A randomised, double-blind, multicentre, therapeutic confirmatory phase 3 clinical trial.

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제1저자 이승환 · 교신저자 조영민

PMID 41417560 PMC12890737 DOI 10.1111/dom.70386 IF 6.1 내분비대사내과

소속 (16)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
Department of Internal Medicine and Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Changwon Hospital Sungkyunkwan University School of Medicine, Changwon, Korea.
Department of Endocrinology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University, College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Inha University of College of Medicine, Incheon, Korea.
Department of Endocrinology and Metabolism, Ajou University Hospital, Ajou University, School of Medicine, Suwon, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University, College of Medicine, Cheonan, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.

Abstract

AIM This study evaluated the efficacy and safety of empagliflozin 10 and 25 mg compared to placebo as add-on treatment for people with type 2 diabetes mellitus (T2DM) uncontrolled after ≥8 weeks of treatment with metformin and sitagliptin.

MATERIALS AND METHODS A randomised, double-blind, multicentre, therapeutic confirmatory, phase 3 clinical trial was conducted in 172 patients with T2DM. Participants with glycosylated haemoglobin (HbA1c) levels 7%-10% receiving sitagliptin and metformin were randomised 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. The primary endpoint was the change in HbA1c from baseline to week 24.

RESULTS After 24 weeks of treatment, HbA1c levels were significantly decreased in the empagliflozin 10 and 25 mg group versus the placebo group; the adjusted mean differences with empagliflozin 10 and 25 mg versus placebo were -0.7% (95% CI -1.0, -0.4; p <.0001) and -0.8% (95% CI -1.1, -0.5; p <.0001), respectively. Fasting plasma glucose levels were also significantly decreased in both empagliflozin groups compared to the placebo group (both p <.0001). More patients reached HbA1c <7% or <6.5% after 24 weeks in the empagliflozin 10 and 25 mg groups versus the placebo group (both p <.05). Efficacy was maintained in the empagliflozin groups during a 28-week extension period. Empagliflozin add-on was associated with improvements in albuminuria and body weight. The incidence of adverse events was similar across groups; add-on empagliflozin was well tolerated.

CONCLUSIONS These results suggest that coadministration of empagliflozin safely improves glycemic control in Korean patients with T2DM uncontrolled by sitagliptin and metformin.

Keywords

clinical trialempagliflozinmetforminsitagliptintype 2 diabetes mellitus

Figures

**FIGURE 2** Changes in glycemic control over time: (A) Mean HbA1c from baseline to 52 weeks. (B) Mean fasting plasma glucose (FPG) from baseline to 52 weeks. Error bars are standard deviation (SD) of the mean. ^aSignificant change compared to placebo (p <.0001).

**FIGURE 3** Proportion of patients achieving HbA1c less than 7.0% or 6.5% at 24 and 52 weeks.

그림 출처: PubMed Central 공개 논문 (PMC12890737)

Conflict of interest statement

SHL received consultation fees from Novo Nordisk and Bayer, and lecture fees from LG Chemical, JW Pharmaceutical, AstraZeneca, Celltrion, and Chong Kun Dang Pharmaceutical Corp. YMC received grants from Daewoong Pharmaceutical, consultation fees from LG Chemical, Hanmi, and Daewoong Pharmaceutical. YMC is an external director of Daewoong Pharmaceutical. IKJ received consultation fees from Chong Kun Dang Pharmaceutical Corp, Daewoong Pharmaceutical, Daiichi Sankyo, Dongwha Pharmaceutical.

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