Efficacy and Safety of Remogliflozin Etabonate, a New Sodium Glucose Co-Transporter-2 Inhibitor, in Patients with Type 2 Diabetes Mellitus: A 24-Week, Randomized, Double-Blind, Active-Controlled Trial
Autor: | S.R. Aravind, Arthur Asirvatham, Jayashri Shembalkar, Ramesh Goyal, Rajesh Gaikwad, Manoj Chawla, Sivakumar Vaidyanathan, Hemant Thacker, Hanmant Barkate, Rahul R. Kodgule, Sagar Katare, Pradnya Kadam, Brij Mohan, Amol Pendse, Hansraj Alva, S. Paramesh, Monika Tandon, R. Balamurugan, Sachin R. Suryawanshi, Mala Dharmalingam |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Adult
Male medicine.medical_specialty Time Factors Adolescent Remogliflozin etabonate Placebo Gastroenterology law.invention 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method Glucosides Sodium-Glucose Transporter 2 law Internal medicine Diabetes mellitus medicine Humans Hypoglycemic Agents Pharmacology (medical) Prodrugs Original Research Article Dapagliflozin Sodium-Glucose Transporter 2 Inhibitors Glycemic Aged business.industry Middle Aged medicine.disease Metformin chemistry Diabetes Mellitus Type 2 030220 oncology & carcinogenesis Pyrazoles Female Glycated hemoglobin business 030217 neurology & neurosurgery medicine.drug |
Zdroj: | Drugs |
ISSN: | 1179-1950 0012-6667 |
Popis: | Background Metformin is the first-line treatment for type 2 diabetes mellitus (T2DM), but many patients either cannot tolerate it or cannot achieve glycemic control with metformin alone, so treatment with other glucose-lowering agents in combination with metformin is frequently required. Remogliflozin etabonate, a novel agent, is an orally bioavailable prodrug of remogliflozin, which is a potent and selective sodium-glucose co-transporter-2 inhibitor. Objective Our objective was to evaluate the efficacy and safety of remogliflozin etabonate compared with dapagliflozin in subjects with T2DM in whom a stable dose of metformin as monotherapy was providing inadequate glycemic control. Methods A 24-week randomized, double-blind, double-dummy, active-controlled, three-arm, parallel-group, multicenter, phase III study was conducted in India. Patients aged ≥ 18 and ≤ 65 years diagnosed with T2DM, receiving metformin ≥ 1500 mg/day, and with glycated hemoglobin (HbA1c) levels ≥ 7 to ≤ 10% at screening were randomized into three groups. Every patient received metformin ≥ 1500 mg and either remogliflozin etabonate 100 mg twice daily (BID) (group 1, n = 225) or remogliflozin etabonate 250 mg BID (group 2, n = 241) or dapagliflozin 10 mg once daily (QD) in the morning and placebo QD in the evening (group 3, n = 146). The patients were followed-up at weeks 1 and 4 and at 4-week intervals thereafter until week 24. The endpoints included mean change in HbA1c (primary endpoint, noninferiority margin = 0.35), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), bodyweight, blood pressure, and fasting lipids. Treatment-emergent adverse events (TEAEs), safety laboratory values, electrocardiogram, and vital signs were evaluated. Results Of 612 randomized patients, 167 (group 1), 175 (group 2), and 103 (group 3) patients with comparable baseline characteristics completed the study. Mean change ± standard error (SE) in HbA1c from baseline to week 24 was − 0.72 ± 0.09, − 0.77 ± 0.09, and − 0.58 ± 0.12% in groups 1, 2, and 3, respectively. The difference in mean HbA1c of group 1 versus group 3 (− 0.14%, 90% confidence interval [CI] − 0.38 to 0.10) and group 2 versus group 3 (− 0.19%; 90% CI − 0.42 to 0.05) was noninferior to that in group 3 (p |
Databáze: | OpenAIRE |
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