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Kim, Kim, Han, Baek, Son, Cha, and Min: Efficacy and Safety of Mitiglinide in Korean Type 2 Diabetic Patients: Prospective Randomised Multicenter Comparative Phase III Study
Original Article
The Journal of Korean Diabetes Association

The Journal of Korean Diabetes Association 2007; 31(2): 163-174.

Published online: 31 March 2007

DOI: https://doi.org/10.4093/jkda.2007.31.2.163

Efficacy and Safety of Mitiglinide in Korean Type 2 Diabetic Patients: Prospective Randomised Multicenter Comparative Phase III Study

Se-Young Kim, Hyo-Jeong Kim, Kyung Ah Han, Se Hyun Baek1, Hyun Sik Son2, Bong Soo Cha3, Kyung Wan Min

Department of Internal Medicine, Eulji University School of Medicine, Korea.

1Department of Internal Medicine, Korea University College of Medicine, Korea.

2Department of Internal Medicine, The Catholic University of Korea College of Medicine, Korea.

3Department of Internal Medicine, Yonsei University College of Medicine, Korea.

Received 8 February 2007       Accepted 20 March 2007

Copyright © 2007 Korean Diabetes Association

Abstract

Background

Mitiglinide, one of the meglitinides, is expected to prevent postprandial hyperglycemia of type 2 diabetes by enhancing early phase insulin secretion. The aim of this study was to verify the efficacy and safety of mitiglinide compared to nateglinide.

Methods

One hundred eleven of diabetic patients were randomised and administered of mitiglinide (n = 56) and nateglinide (n = 55) before a meal time for 12 weeks. The changes of HbA1c, fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) were analyzed. The safety of this drug was investigated as well.

Results

The change of HbA1c was not significantly different between two groups (-0.77 ± 1.08% in mitiglinide vs. -0.66 ± 0.79% in nateglinide, P = 0.57). The reduction of FPG (-12.2 ± 25.0 mg/dL vs. -6.1 ± 22.3 mg/dL, P = 0.218), PPG 1 hr (-48.0 ± 47.1 mg/dL, vs. -29.4 ± 43.2 mg/dL, P = 0.051), and PPG 2 hr (-59.2 ± 58.0 mg/dL vs. -43.3 ± 59.0 mg/dL, P = 0.194) were not significantly different between the mitiglinide and the nateglinide, respectively. Drug-related adverse effects were not different between two groups (16.1% in mitiglinide vs. 27.8% in nateglinide, P = 0.137). The frequency of hypoglycemic events were not different between two groups (8.9% in mitiglinide vs. 14.8% in nateglinide, P = 0.339). There were two patients who had complained shoulder pain in the mitiglinide or deterioration of visual acuity in the nateglinide, but those were found to be unrelated with medications.

Conclusion

This study showed that mitiglinide had reduced HbA1c as similar to nateglinide and that significantly improved HbA1c, FPG and PPG during 12 weeks of treatment. The safety of mitiglinide was also comparable to nateglinide. Mitiglinide could be used as an effective glucose-lowering agent by enhancing early insulin secretion and reducing postprandial glucose excursion, and thereby might contribute long-term cardioprotective effect in Korean type 2 diabetic patients.

Keywords: Efficacy, Korean type 2 diabetes, Mitiglinide, Nateglinide, Safety

Figures and Tables

Fig. 1
Disposition of screened patients in the intention to treat population.
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Fig. 2
The change of HbA1c level. A, The graph shows the changes in HbA1c between two groups for 12 weeks by paired t-test. There are significant reductions of HbA1c in both groups (**; P < 0.001); B, The graph shows the difference of HbA1c changes between two groups for 12 weeks by independent t-test. There is no significant difference of HbA1c between two groups (P = 0.57).
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Fig. 3
The % of patients according to the HbA1c reductions after 12 week treatment. A, Δ HbA1c ≥ 1%; B, Δ HbA1c ≥ 0.5%. There are no significant differences of % of patients between two groups by independent t-test, respectively.
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Fig. 4
The change of FPG level. A, The graph shows the changes in FPG for two groups for 12 weeks by paired t-test. There are significant reductions of FPG in both groups (*; P < 0.05, **P < 0.001); B, The graph shows the difference of FPG changes between two groups for 12 weeks by independent t-test. There is no significant difference of HbA1c between two groups (P = 0.218).
jkda-31-163-g004
Fig. 5
The change of PPG 1 hr level. A, The graph shows the changes in PPG 1 hr for two groups for 12 weeks by paired t-test. There are significant reductions of PPG 1 hr in both groups (**; P < 0.001); B, The graph shows the difference of PPG 1 hr changes between two groups for 12 weeks by independent t-test. There is no significant difference of PPG 1 hr between two groups (P = 0.051).
jkda-31-163-g005
Fig. 6
The change of PPG 2 hr level. A, The graph shows the changes in PPG 2hr for two groups for 12 weeks by paired t-test. There are significant reductions of PPG 2hr in both groups (**; P < 0.001); B, The graph shows the difference of PPG 2 hr changes between two groups for 12 weeks by independent t-test. There is no significant difference of PPG 2 hr between two groups (P = 0.194).
jkda-31-163-g006
Table 1
Clinical characteristics of subjects with type 2 diabetes mellitus
jkda-31-163-i001

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