Effect of the combination of mitiglinide and metformin on glycemic control in patients with type 2 diabetes mellitus

• Published in: Journal of diabetes investigation 2010-08, Vol.1 (4), p.143-148
• Main Authors: Cho, Young Min, Koo, Bo Kyung, Son, Ho Young, Lee, Kwang Woo, Son, Hyun Shik, Choi, Dong Seop, Kim, Bo Wan, Kim, Yong Ki, Lee, Moon Kyu, Lee, Hyun Chul, Min, Kyung Wan, Chung, Min Young, Baek, Hong Sun, Kim, Youngkun, Yoo, Hyung Joon, Park, Kyong Soo, Lee, Hong Kyu
• Format: Article
• Language: English
• Subjects: Clinical Trial; Metformin; Mitiglinide; Type 2 diabetes
• ISSN: 2040-1116; 2040-1124
• DOI: 10.1111/j.2040-1124.2010.00023.x

Aims/Introduction:  Mitiglinide is the newest drug in the meglitinide family. It increases the early‐phase insulin release through rapid association‐dissociation kinetics in the pancreatic β cells. The efficacy and safety of adding meglitinide to metformin monotherapy in patients with type 2 diabetes are unknown. Materials and Methods:  We carried out a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who showed inadequate glycemic control with metformin monotherapy. Subjects with glycated hemoglobin (HbA1c) >7.0% after an 8‐week metformin run‐in phase were randomized to a 16‐week trial phase with metformin plus mitiglinide (Met + Mit) or metformin plus placebo (Met + Pcb). Results:  Compared with the Met + Pcb group, the Met + Mit group showed a greater reduction in HbA1c (−0.7 ± 0.6%vs−0.4 ± 0.7%, P = 0.002), fasting plasma glucose (−0.77 ± 1.76 mmol/L vs−0.05 ± 1.60 mmol/L, P = 0.015) and 2‐h postprandial glucose (−3.76 ± 3.57 mmol/L vs−0.84 ± 3.07 mmol/L, P