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
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Diabetes Obesity and Metabolism
DOI: 10.1111/dom.70386
Institutions: The Catholic University of Korea Seoul St. Mary's Hospital, Catholic University of Korea, Eulji University, Eulji Medical Center, Hallym University Dongtan Sacred Heart Hospital, Hallym University, Yonsei University, Inje University Sanggye Paik Hospital, Daegu Catholic University, Daegu Catholic University Medical Center, Samsung Changwon Hospital, Sungkyunkwan University, Keimyung University Dongsan Hospital, Keimyung University, Inha University, Korea University Medical Center, Inha University Hospital, Korea University Anam Hospital, Yonsei University Health System, Ajou University Hospital, Ajou University, Kyung Hee University, Kyung Hee University Hospital at Gangdong, Soonchunhyang University, Soonchunhyang University Hospital Cheonan, Seoul National University, Seoul National University Hospital
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,380
OpenAlex ID: W4417507267