Mitiglinide is a rapid- and short-acting insulinotropic
sulfonylurea receptor ligand and features rapid
hypoglycemic action. To date, no prospective study has evaluated the use of
mitiglinide in diabetic patients receiving
hemodialysis (HD). In this study we evaluated the efficacy and safety of
mitiglinide in diabetic patients on HD. Following an 8-week baseline period, we enrolled a study population of poorly controlled diabetic HD patients who had mean
hemoglobin (Hb)A(1c) levels greater than 6.5% at baseline and who were not receiving
insulin injection
therapy. Patients were administered
mitiglinide, 15 mg for those who were younger than 70 years and 7.5 mg for those who were 70 years and older, daily with each meal for the first 8 weeks. Subsequently, the doses were titrated by dose-doubling to a maximum of 30 mg/day if no adverse effects appeared. The efficacy was determined by monitoring
glycemic control (plasma
glucose, HbA(1c), and glycated
albumin levels). Safety and tolerance were determined by monitoring clinical and laboratory parameters during the 24-week study period. The average final dose of
mitiglinide was 20.0 +/- 8.6 mg daily.
Mitiglinide was effective in reducing not only HbA(1c) and glycated
albumin but also fasting plasma
glucose levels from baseline from week 4 after the start of treatment. The agent was also effective in reducing
triglyceride levels. No serious adverse effects such as
hypoglycemia or liver impairment were observed in any patient. However, we could not completely rule out the possibility of a
hypoglycemic episode, including silent
hypoglycemia due to autonomic neuropathy, and therefore further clinical studies are required. It is necessary to adjust the dose of
mitiglinide according to the status of
glycemic control or
hypoglycemic symptoms of individual patients. Although
mitiglinide was effective as a treatment for diabetic patients on HD
therapy, it should be initiated at a lower dose in the HD population, compared with the general population of diabetic patients.
Mitiglinide can be safely used for diabetic patients on HD, if careful attention is paid to
hypoglycemia.