Elena A Christofides, Orlando Puente, Paul Norwood, Douglas Denham, Hiralal Maheshwari, Michael Lillestol, Terence Hart, Samer Nakhle, Anurekha Chadha, David Fitz-Patrick, Danny Sugimoto, Joseph Soufer, Douglas Young, Mark Warren, David Huffman, John Reed, Harold Bays, Samir Arora, Barbara Rizzardi, Raymond Tidman, Marc Rendell, Kimball A Johnson
AIM: To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. METHODS: This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks...
April 1, 2024: Diabetes, Obesity & Metabolism