Effect of mitiglinide on glycemic control over 52 weeks in Japanese type 2 diabetic patients insufficiently controlled with pioglitazone monotherapy.
This study was performed to examine the efficacy and safety of the rapid- and short-acting insulinotropic SUR ligand mitiglinide given as add-on therapy for 52 weeks in type 2 diabetic patients whose blood glucose was insufficiently controlled by pioglitazone monotherapy. Type 2 diabetic patients aged > or = 20 years with postprandial plasma glucose (PPG1 or 2) > or = 200 mg/dL and glycated hemoglobin (HbA(1C)) 6.5-<9.0% despite receiving pioglitazone 15-45 mg/day were additionally treated with concomitant mitiglinide 10 mg tid p.o. for a total treatment period of 52 weeks. In 171 patients recruited, HbA(1C) was significantly reduced from 7.64 +/- 0.77% at baseline to 6.84 +/- 0.73%, 6.64 +/- 0.64%, 6.67 +/- 0.57% and 6.81 +/- 0.65% at weeks 16, 28, 40, and 52, respectively. Over half the patients achieved HbA(1C) target of <7.0%, and one third <6.5%. Significant reductions in fasting plasma glucose (FPG) and PPG 1 and 2 hours after a meal versus baseline were noted at all time-points evaluated. The most frequently noted adverse reactions were hypoglycemic symptoms, weight gain, and peripheral edema (all mild). In type 2 diabetic patients combination therapy with mitiglinide and pioglitazone exerted significant long-term improvements in HbA(1C), FPG, and PPG and was well tolerated. This drug combination therapy is a promising means of alleviating insufficient pancreatic insulin secretion and insulin resistance.
Kaku
Kohei
K
Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan. kka@med.kawasaki-m.ac.jp
Tanaka
Shun-Ichi
S
Origasa
Hideki
H
Kikuchi
Masatoshi
M
Akanuma
Yasuo
Y
D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D054833:Isoindoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D015430:Weight Gain / Q000187:drug effects
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D054833:Isoindoles; D000077205:Pioglitazone; D045162:Thiazolidinediones; C087255:mitiglinide