title: Improvement of both fasting and postprandial glycemic control by the two-step addition of miglitol and mitiglinide to basal insulin therapy: a pilot study.
abstract: BACKGROUND
  Combination therapy consisting of basal insulin and oral hypoglycemic agents (OHAs) is effective for the treatment of type 2 diabetes (T2DM) that cannot be adequately controlled using OHAs alone. Though basal insulin with metformin or sulfonylurea is an effective therapy, it cannot reduce postprandial glycemia without the risk of hypoglycemia. We examined a two-step regimen consisting of the addition of postprandial hypoglycemic agents (an alpha-glucosidase inhibitor and a glinide) in patients whose T2DM was poorly controlled using basal insulin therapy.
  
  
  METHODS
  Inpatients between the ages of 30-79 years who had T2DM and an HbA1c level of more than 7.0% were recruited. The patients were treated with once-daily insulin glargine with or without metformin, depending on the patient's age and renal function. Insulin glargine was titrated to achieve a target fasting glucose level of 70-130 mg/dL as a first step (STEP0). If the 2-hour postprandial glucose (PBG) level was higher than the target of 180 mg/dL, miglitol treatment (150 mg/day) was initiated, with dose adjustments (75-225 mg) allowed depending on abdominal symptoms and the PBG (STEP1). If the PBG of the patients remained higher than the target after 3 days of treatment, mitiglinide (30 mg/day, titrated up to 60 mg) was added (STEP2). We then evaluated the proportion of patients who achieved the target PBG before and after the two-step regimen. Continuous Glucose Monitoring (CGM) was performed throughout the two-step protocol in most of the patients.
  
  
  RESULTS
  Of the 16 patients who were recruited (median age, 67.0 [58.0-71.0] years; body mass index, 25.0 [22.0-27.9] kg/m(2); HbA1c level at admission, 9.1% [8.35-10.4%]), 1 patient (6.25%) achieved the target PBG at STEP 0 and 14 patients (87.5%) had achieved the target PBG at the end of the treatment protocol (P = 0.002). CGM showed a significant decrease in the glucose level at each step of the protocol. The standard deviations in the CGM glucose levels for 24 hours, MAGE, and M-value also improved.
  
  
  CONCLUSIONS
  The two-step addition of postprandial hypoglycemic agents to basal insulin therapy is potentially effective and safe for decreasing both the fasting and postprandial glucose levels.
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan ; Division of General Medicine, Jichi Medical University Graduate School of Medicine, Tochigi, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Ihana
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan ; Division of General Medicine, Jichi Medical University Graduate School of Medicine, Tochigi, Japan.
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Tsujimoto
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan.
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Yamamoto-Honda
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan.
authors.forename: Miyako
authors.initials: M
authors.lastname: Kishimoto
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kajio
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Noto
authors.affiliation: Division of General Medicine, Jichi Medical University Graduate School of Medicine, Tochigi, Japan ; First Department of Comprehensive Medicine, Saitama Medical Center, Jichi Medical University School of Medicine, Saitama, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kakei
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine Center Hospital, Tokyo, Japan ; Department of Diabetes Research, Diabetes Research Center, National, Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Noda
keywords: Continuous glucose monitoring (CGM); Glucose fluctuation; Insulin glargine; Miglitol; Mitiglinide; Postprandial hyperglycemia