15-PUB: A Single-Center, Open-Label, Fixed-Sequence Clinical Study to Evaluate the Pharmacokinetic Effects of Supaglutide on Digoxin or Metformin in Healthy Subjects

• Published in: Diabetes (New York, N.Y.) Vol. 73; no. Supplement_1; p. 1
• Main Authors: JINJIE, HE, JING, ZHANG, ANWAR, DILBAR, HAIYA, WU, WANG, QINGHUA, WU, XIAOJIE
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 14.06.2024
• Subjects: Antidiabetics; Diabetes mellitus; Digoxin; Fatty liver; GLP-1 receptor agonists; Injection; Liver diseases; Metformin; Oral administration; Pharmacokinetics; Tablets
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db24-15-PUB

Introduction: Supaglutide (supa) is a novel GLP-1 receptor agonist as subcutaneous once-weekly administration for the treatment of diabetes mellitus, obesity, and nonalcoholic fatty liver disease. Objective: This is an open label, fixed-sequence clinical study to evaluate the pharmacokinetic effects of multiple injections of supa on a single dose of digoxin or multiple doses of metformin. Methods: 32 healthy subjects were assigned to 2 parallel groups (16 cases in each), digoxin tablets (Group A), and metformin hydrochloride tablets (Group B), both combined with supa injection. Results: After a single oral dose of 0.25 mg digoxin in healthy subjects, the coadministration of supa injection had no effect on the AUC0-last of digoxin, a reduction in Cmax by about 24%, and an increase in the AUC0-inf by about 15% compared with that of the digoxin administration alone. After multiple BID oral administration of 500 mg metformin, coadministration of supa injection had no effect on Cmax and an increase in AUC0-inf by approximately 15%, compared to the metformin administration alone (Figure). These results suggest that coadministration of supa on digoxin and metformin exposure is not clinically significant. Conclusion: Supaglutide injection can be used in combination with digoxin or metformin without dose adjustment.