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 Baek; Hyun Sik Son; Bong Soo Cha; Kyung Wan Min

doi:10.4093/jkda.2007.31.2.163

Articles

Page Path: HOME > Diabetes Metab J > Volume 31(2); 2007 > Article

Randomized Controlled Trial 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 Baek, Hyun Sik Son, Bong Soo Cha, Kyung Wan Min; Diabetes & Metabolism Journal 2007;31(2):163-174
DOI: https://doi.org/10.4093/jkda.2007.31.2.163
Published online: March 1, 2007

2,620 Views
26 Download
3 Crossref
0 Scopus

¹Department of Internal Medicine, Eulji University School of Medicine, Korea.
²Department of Internal Medicine, Korea University College of Medicine, Korea.
³Department of Internal Medicine, The Catholic University of Korea College of Medicine, Korea.
⁴Department of Internal Medicine, Yonsei University College of Medicine, Korea.

prev next

Full Article

Download PDF

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

Figure & Data

References

Citations

Citations to this article as recorded by

Monotherapy in Type 2 Diabetes Mellitus Patients 2017: A Position Statement of the Korean Diabetes Association
Sang Youl Rhee
The Journal of Korean Diabetes.2018; 19(1): 15. CrossRef
Monotherapy in patients with type 2 diabetes mellitus
Sang Youl Rhee, Hyun Jin Kim, Seung-Hyun Ko, Kyu Yeon Hur, Nan-Hee Kim, Min Kyong Moon, Seok-O Park, Byung-Wan Lee, Kyung Mook Choi, Jin Hwa Kim
The Korean Journal of Internal Medicine.2017; 32(6): 959. CrossRef
Monotherapy in Patients with Type 2 Diabetes Mellitus
Sang Youl Rhee, Hyun Jin Kim, Seung-Hyun Ko, Kyu-Yeon Hur, Nan-Hee Kim, Min Kyong Moon, Seok-O Park, Byung-Wan Lee, Kyung Mook Choi, Jin Hwa Kim
Diabetes & Metabolism Journal.2017; 41(5): 349. CrossRef

Cite

CITE: export Copy Format; Close

Download Citation

Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

Format:

RIS — For EndNote, ProCite, RefWorks, and most other reference management software
BibTeX — For JabRef, BibDesk, and other BibTeX-specific software

Include:

Citation for the content below
Citation and abstract for the content below

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

Korean Diabetes J. 2007;31(2):163-174. Published online March 1, 2007

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

Related articles

The Efficacy and Safety of Moderate-Intensity Rosuvastatin with Ezetimibe versus High-Intensity Rosuvastatin in High Atherosclerotic Cardiovascular Disease Risk Patients with Type 2 Diabetes Mellitus: A Randomized, Multicenter, Open, Parallel, Phase 4 Study

About this article

Kim SY, Kim HJ, Han KA, Baek SH, Son HS, Cha BS, Min KW. Efficacy and Safety of Mitiglinide in Korean Type 2 Diabetic Patients: Prospective Randomised Multicenter Comparative Phase III Study.. Diabetes Metab J. 2007;31(2):163-174.

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

Download citation ↓