| Addition of mitiglinide to pioglitazone monotherapy improves overall glycemic control in Japanese patients with type 2 diabetes: a randomized double blind trial. | |
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MedLine Citation:
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PMID: 19352048 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A 16-week, multicenter, randomized, double blind, parallel-group study was performed to examine whether additional administration of mitiglinide improves glycemic control in Japanese type 2 diabetic patients who are insufficiently controlled by pioglitazone monotherapy. Japanese adult type 2 diabetic patients were at first treated with diet plus pioglitazone 15-30 mg/day for 4 weeks then randomized to receive additional mitiglinide 5 or 10 mg or placebo tid for a further 16 weeks. In all, 381 patients were randomized. At final evaluation, glycated hemoglobin (HbA(1C)) was reduced by (mean +/- SD) -0.02 +/- 0.60% in the pioglitazone monotherapy group and by -0.45 +/- 0.77% and -0.67 +/- 0.59% in the mitiglinide 5 and 10 mg combination groups, respectively (both p<0.001 vs. pioglitazone monotherapy group). The percentage of patients who achieved HbA(1C) targets was significantly (p<0.001) higher in the mitiglinide combination groups than in the pioglitazone monotherapy group. Significant improvements in fasting plasma glucose and postprandial plasma glucose were noted in the mitiglinide combination groups versus the pioglitazone monotherapy group. No increase in adverse events was noted when mitiglinide was administered concomitantly with pioglitazone monotherapy. Hypoglycemic adverse events were infrequently and similarly observed in all three groups. Body weight gain and edema presented no clinical problem. HbA(1C) was significantly improved in the mitiglinide combination groups compared with the pioglitazone monotherapy group, and significantly more patients achieved HbA(1C) targets. Therefore mitiglinide effectively improves glycemic control in type 2 diabetic patients who are inadequately controlled by pioglitazone monotherapy. |
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Authors:
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Kohei Kaku; Shun-ichi Tanaka; Hideki Origasa; Masatoshi Kikuchi; Yasuo Akanuma |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-04-07 |
Journal Detail:
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Title: Endocrine journal Volume: 56 ISSN: 1348-4540 ISO Abbreviation: Endocr. J. Publication Date: 2009 |
Date Detail:
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Created Date: 2009-08-26 Completed Date: 2009-11-06 Revised Date: 2011-06-16 |
Medline Journal Info:
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Nlm Unique ID: 9313485 Medline TA: Endocr J Country: Japan |
Other Details:
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Languages: eng Pagination: 657-64 Citation Subset: IM |
Affiliation:
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Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School, Okayama, Japan. kka@med.kawasaki-m.ac.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Blood Glucose / metabolism Diabetes Mellitus, Type 2 / drug therapy* Diabetic Diet Double-Blind Method Drug Therapy, Combination Female Hemoglobin A, Glycosylated / metabolism Humans Hypoglycemic Agents / administration & dosage* Isoindoles / administration & dosage* Male Middle Aged Thiazolidinediones / administration & dosage* |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Isoindoles; 0/Thiazolidinediones; 0/mitiglinide; 111025-46-8/pioglitazone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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