J Korean Diabetes Assoc.  2007 Mar;31(2):163-174. 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

• Kim SY
• Kim HJ
• Han KA
• Baek SH
• Son HS
• Cha BS
• Min KW

• KMID: 2008086
• DOI: http://doi.org/10.4093/jkda.2007.31.2.163

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.

Keyword

Efficacy; Korean type 2 diabetes; Mitiglinide; Nateglinide; Safety

MeSH Terms

Blood Glucose
Fasting
Glucose
Humans
Hyperglycemia
Insulin
Meals
Prospective Studies*
Shoulder Pain
Visual Acuity
Glucose
Insulin

Figure

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  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).

• 

  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.

• 

  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).

• 

  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).

• 

  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).

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