Open AccessEffect of the combination of mitiglinide and metformin on glycemic control in patients with type 2 diabetes mellitus
Author(s) -
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
Publication year - 2010
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/j.2040-1124.2010.00023.x
Subject(s) - metformin , medicine , glycemic , postprandial , glycated hemoglobin , type 2 diabetes , diabetes mellitus , type 2 diabetes mellitus , gastroenterology , placebo , adverse effect , endocrinology , insulin , alternative medicine , pathology
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 (HbA 1c ) >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 HbA 1c (−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 < 0.0001). The proportion of the patients who achieved the target HbA 1c value of <7% at the end of the study was also higher in the Met + Mit group than the Met + Pcb group (49.3% vs 28.8%, P = 0.016). There were no differences in the adverse event rates between groups. Conclusions: Combination therapy with metformin and mitiglinide is effective and safe for the treatment of patients with type 2 diabetes who have inadequate glycemic control with metformin monotherapy. (J Diabetes Invest, doi: 10.1111/j.2040‐1124.2010.00023.x, 2010)