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Effect of the Α-Glucosidase Inhibitor Miglitol on the Glucose Profile in Japanese Type 2 Diabetic Patients Receiving Multiple Daily Insulin Injections

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Effect of the Α-Glucosidase Inhibitor Miglitol on the Glucose Profile in Japanese Type 2 Diabetic Patients Receiving Multiple Daily Insulin Injections Endocrine Journal 2012, 59 (4), 345-352 ORIGINAL Effect of the α-glucosidase inhibitor miglitol on the glucose profile in Japanese type 2 diabetic patients receiving multiple daily insulin injections Hiroyuki Kato, Akio Ohta, Suzuko Kobayashi, Satoshi Ishii, Yukiyoshi Sada, Hidetoshi Kobayashi, Shintaro Ohmori, Akihiko Kondo, Takuyuki Katabami, Junro Fuse, Hisashi Fukuda, Yoshio Nagai and Yasushi Tanaka Department of Internal Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan Abstract. Strict postprandial glycemic control may have a preventive effect on atherogenesis in patients with type 2 diabetes. The α-glucosidase inhibitor (α-GI) miglitol is useful for controlling the early postprandial increase of glucose, but the combined effect of miglitol and multiple daily insulin injections (MDI) on glucose excursion has not been evaluated. First, we retrospectively compared the daily glucose profile, evaluated by self-monitoring of blood glucose (SMBG) at nine times on the day before discharge from hospital, between type 2 diabetic patients receiving MDI (n=81) or MDI plus miglitol at 150 mg daily (n=24). Second, we prospectively examined the effect of adding miglitol to MDI on the daily glucose profile (SMBG) in 19 other type 2 diabetic patients. Although the daily insulin dosage and the glucose level before meals did not differ between the two groups, the 1-h postprandial glucose level after each meal, 2-h glucose level after lunch and dinner, mean and standard deviation of glucose, and amplitude of glucose excursion were significantly lower or smaller in the MDI plus miglitol group than in the MDI group. All of these glucose parameters were significantly improved by adding miglitol to MDI in the prospective cohort of 19 patients. In conclusion, adding miglitol to MDI reduces postprandial glucose levels and attenuates daily glucose fluctuation in type 2 diabetic patients. This trial was registered with UMIN (no. UMIN000005383). Key words: Daily glucose profile, Miglitol, Multiple daily insulin injections THE POSTPRANDIAL plasma glucose level is patients undergoing prospective follow up for 5 years thought to be a risk factor for the cardiovascular com- [5]. Recently, Esposito et al. reported that the post- plications of diabetes independently of fasting plasma prandial peak glucose level determined by self-moni- glucose (FPG) [1-3]. Hanefeld et al. found that the 1-h toring of blood glucose (SMBG) at home was associ- postprandial glucose level after breakfast, but not FPG, ated with carotid artery intima-media thickness (IMT), was a risk factor for myocardial infarction in an 11-year a surrogate marker of atherosclerosis, independently of prospective study of patients with newly diagnosed hemoglobin A1c (HbA1c) in type 2 diabetic patients [6], non-insulin dependent diabetes mellitus (NIDDM) and that there was an incremental glucose peak within [4]. Another study showed that the 2-h postprandial 1 hour of starting either main meal (lunch or dinner). glucose level after lunch, but not FPG, was a strong Similarly, Hu et al. showed that the postchallenge glu- predictor of cardiovascular events in type 2 diabetic cose spike (the difference between the maximal plasma glucose level during a 75 g oral glucose tolerance test Submitted Oct. 6, 2011; Accepted Jan. 19, 2012 as EJ11-0283 and the baseline fasting plasma glucose level) was Released online in J-STAGE as advance publication Feb. 2, 2012 associated with carotid artery IMT independently of Correspondence to: Akio Ohta, M.D., Department of Internal HbA1c in type 2 diabetic patients [7]. Although post- Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae- prandial glucose levels were not measured after every ku, Kawasaki, Kanagawa 216-8511, Japan meal in these studies, the findings imply that control- E-mail: [email protected] ling excessive early postprandial hyperglycemia could ©The Japan Endocrine Society 346 Kato et al. help to prevent cardiovascular complications. as the National Glycohemoglobin Standardizaion Rapid-acting insulin preparations, such as Insulin Program (NGSP) equivalent value, which was calcu- Aspart or Insulin Lyspro, are useful to improve post- lated as HbA1C (NGSP) (%) = HbA1C (JDS) (%) + 0.4%, prandial hyperglycemia, since these insulins have sub- based on the relationship of HbA1C (NGSP) values to stituted amino acids at position 28 and/or 29 and are HbA1C (JDS) (%) values measured with the Japanese absorbed more quickly to act more rapidly than reg- standard and measurement method [12]. Serum GA ular human insulin [8, 9]. The α-glucosidase inhibi- was measured by an enzymatic method using an albu- tor (α-GI) miglitol is a unique oral antidiabetic agent min-specific protease (ketoamine oxidase) and an albu- that suppresses the early postprandial increase of glu- min assay reagent (Lucica GA-L, Asahi Kasei Pharma, cose more potently than other α-GIs, since miglitol is Tokyo, Japan). All patients were given instructions absorbed from the small intestine after oral administra- about how to perform SMBG with a One Touch Ultra tion and has a stronger action especially in the proxi- (Johnson and Johnson KK, Tokyo, Japan) by educa- mal small bowel [10, 11]. However, it remains unclear tional nurses. All patients started MDI after admis- whether the combination of miglitol and a rapid-act- sion, and their insulin dosage was adjusted to achieve ing insulin analog can further improve the early post- a glucose level <140 mg/dL, <200 mg/dL, and <180 prandial glucose profile compared with insulin alone. mg/dL before, 1 h after, and 2 h after meals, respec- In the present study, we retrospectively compared tively, in the absence of hypoglycemia (<70 mg/dL). the daily glucose profile obtained by SMBG between When the 1-h or 2-h postprandial glucose target could type 2 diabetic patients receiving multiple daily insu- not be achieved by MDI within one week after hospi- lin injections (MDI), i.e., rapid-acting insulin (Insulin talization despite reaching a preprandial glucose <140 Aspart or Insulin Lyspro) before each meal and long mg/dL, miglitol was added at 150 mg daily (50 mg - acting insulin (Insulin Glargine or Insulin Detemir) just before each meal). Other oral antidiabetic agents before bedtime, without an α-GI versus MDI plus were not changed during admission. All patients per- miglitol. In addition, we prospectively evaluated the formed SMBG at nine times (before each meal and 1 effect of adding miglitol to MDI on the daily glucose h and 2 h after each meal) on the day before discharge, profile (SMBG) in other type 2 diabetic patients. and the daily glucose profile of the patients treated by MDI alone (MDI group, n=81) was compared with that Materials and Methods of patients receiving MDI plus miglitol (MDI + Mig group, n=24). Subjects A total of 124 patients with type 2 diabetes admit- Effect of combined therapy on postprandial glucose ted to St. Marianna University Hospital (Kanagawa, In 19 patients receiving MDI who had stable pre- Japan) in 2009-2010 were studied, including 71 men prandial glucose levels <140 mg/dL, but inadequate and 53 women aged 60 ± 12 years (mean ± SD). They postprandial glycemic control, miglitol was added at were admitted to hospital for diabetes education and 150 mg daily (50 mg just before each meal) without improvement of glycemic control, and achieved good changing the insulin dosage. Other oral antidiabetic control by MDI with a glucose level of <140 mg/dL agents were not changed. To evaluate the effect of add- before each meal. The inclusion for this study crite- ing miglitol on the glucose profile, SMBG was done at rion was a glucose level <140 mg/dL before each meal nine time points on the day before and 7 or 8 days after without any symptoms of hypoglycemia throughout starting miglitol. the day. The exclusion criteria were pregnancy, any severe illness, chronic liver disease, thyroid disease, Statistical analysis malignancy, and a history of abdominal surgery. All Results are presented as the mean ± SD. Comparison patients gave written informed consent and the study of mean values was done by the paired or unpaired was approved by the Ethics Committee of St. Marianna t-test. All analyses were performed with Stat-View University School of Medicine (No. 1226). software (Abacus Concepts, Berkeley, CA) and statis- tical significance was accepted atp <0.05. Comparison of MDI with MDI plus miglitol On the day of admission, HbA1C (%) was estimated Miglitol with multiple insulin injections 347 Results of glucose excursion were lower or smaller in patients treated with MDI plus miglitol than in patients receiv- Retrospective study ing MDI alone, although there was no difference of The clinical profile on admission and a compari- their daily insulin dosage. Adding miglitol to MDI son of the daily insulin dose and glucose excursion decreased the early postprandial glucose surge after between the two treatment groups on the day before each meal, even in patients who had not achieved good discharge are shown in Table 1. The age, gender, BMI, postprandial glucose levels with MDI, resulting in HbA1c, and GA did not differ between the two groups reduction of the mean, SD, and amplitude of glucose. on admission. The daily dosages of rapid-acting and Our results suggested that combined therapy with MDI long - acting insulin, as well as the total insulin dose, plus miglitol achieves better control of glucose excur- also did not differ between the two groups. However, sion compared with MDI alone. Physicians some- both the mean and SD of the daily glucose level were times encounter patients without a decrease of the 1-h significantly lower in the MDI + Mig group than in the postprandial glucose level despite an increase of their MDI group on the day before discharge, and the ampli- insulin dose.
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