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


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 < 0.0001). The proportion of the patients who achieved the target HbA1c 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).
Department of Internal Medicine, Seoul National University College of Medicine.
Young Min
YM
Cho
Department of Internal Medicine, Seoul National University College of Medicine.
Bo Kyung
BK
Koo
Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea.
Ho Young
HY
Son
Department of Internal Medicine, The Catholic University of Korea.
Kwang Woo
KW
Lee
Department of Internal Medicine, Uijeongbu St. Mary Hospital, The Catholic University of Korea.
Hyun Shik
HS
Son
Department of Internal Medicine, Korea University College of Medicine, Seoul.
Dong Seop
DS
Choi
Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu.
Bo Wan
BW
Kim
Department of Internal Medicine, Pusan National University College of Medicine, Busan.
Yong Ki
YK
Kim
Department of Internal Medicine, SungKyunKwan University School of Medicine.
Moon Kyu
MK
Lee
Department of Internal Medicine, Yonsei University College of Medicine.
Hyun Chul
HC
Lee
Department of Internal Medicine, Eulji University School of Medicine, Seoul.
Kyung Wan
KW
Min
Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju.
Min Young
MY
Chung
Department of Internal Medicine, Chonbuk National University College of Medicine, Jeonju.
Hong Sun
HS
Baek
Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon.
Youngkun
Y
Kim
Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea.
Hyung Joon
HJ
Yoo
Department of Internal Medicine, Seoul National University College of Medicine.
Kyong Soo
KS
Park
Department of Internal Medicine, Seoul National University College of Medicine.
Hong Kyu
HK
Lee
Metformin; Mitiglinide; Type 2 diabetes