Exenatide Exhibits Dose-Dependent Effects on Glycemic Control over 12 Weeks in Japanese Patients with Suboptimally Controlled Type 2 Diabetes

• Published in: Endocrine Journal 2009, Vol.56(3), pp.415-424
• Main Authors: KADOWAKI, Takashi, NAMBA, Mitsuyoshi, YAMAMURA, Ayuko, SOWA, Hideaki, WOLKA, Anne M, BRODOWS, Robert G
• Format: Article
• Language: English
• Subjects: Aged; Amylases - blood; Blood Glucose - drug effects; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Dose response; Exenatide; Female; Glycemic control; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Japan; Lipids - blood; Male; Middle Aged; Peptides - administration & dosage; Peptides - adverse effects; Peptides - therapeutic use; Sulfonylurea Compounds - therapeutic use; Type 2 diabetes; Venoms - administration & dosage; Venoms - adverse effects; Venoms - therapeutic use
• ISSN: 0918-8959; 1348-4540
• DOI: 10.1507/endocrj.K08E-296

This study assessed the dose-dependent efficacy and safety of exenatide over 12 weeks in Japanese patients with type 2 diabetes suboptimally controlled despite therapeutic doses of sulfonylurea (SU), SU plus biguanide, or SU plus thiazolidinedione. Patients were randomly assigned to placebo (N = 40), 2.5 μg (N = 38), 5 μg (N = 37), or 10 μg (N = 38) exenatide administered subcutaneously twice daily (BID). Patients randomly assigned to 10 μg exenatide received 5 μg BID for the first 4 weeks, with the dose escalated to 10 μg BID for the final 8 weeks. Patients were 60.3 ± 9.7 years old, with body mass index 25.3 ± 4.3 kg/m2 and hemoglobin A1c (HbA1c) 8.0 ± 0.8%. Baseline-to-endpoint HbA1c changes (%) were +0.02 ± 0.1 (placebo), -0.9 ± 0.1 (2.5 μg), -1.2 ± 0.1 (5 μg), and -1.4 ± 0.1 (10 μg) (all p < 0.001 vs. placebo). Of patients with baseline HbA1c -7%, 5.1% (placebo), 50.0% (2.5 μg), 71.4% (5 μg), and 79.4% (10 μg) achieved HbA1c