Diabetology & Metabolic Syndrome | |
Improvement of both fasting and postprandial glycemic control by the two-step addition of miglitol and mitiglinide to basal insulin therapy: a pilot study | |
Mitsuhiko Noda4  Masafumi Kakei2  Hiroshi Noto3  Hiroshi Kajio3  Miyako Kishimoto3  Ritsuko Yamamoto-Honda3  Tetsuro Tsujimoto1  Noriko Ihana1  | |
[1] 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;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 | |
关键词: Continuous glucose monitoring (CGM); Glucose fluctuation; Postprandial hyperglycemia; Insulin glargine; Mitiglinide; Miglitol; | |
Others : 803796 DOI : 10.1186/1758-5996-6-48 |
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received in 2013-12-24, accepted in 2014-03-24, 发布年份 2014 | |
【 摘 要 】
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/m2; 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.
【 授权许可】
2014 Ihana et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20140708045913350.pdf | 641KB | download | |
Figure 3. | 78KB | Image | download |
Figure 2. | 35KB | Image | download |
Figure 1. | 64KB | Image | download |
【 图 表 】
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【 参考文献 】
- [1]The Committee of the Japan Diabetes Society on the diagnostic criteria of diabetes mellitus: Report of the Committee on the classification and diagnostic criteria of diabetes mellitus. Diabetol Int 2010, 1:2-20.
- [2]Kosaka K, Kuzuya T, Hagura R, Yoshinaga H: Insulin response to oral glucose load is consistently decreased in established non-insulin-dependent diabetes mellitus: the usefulness of decreased early insulin response as a predictor of non-insulin-dependent diabetes mellitus. Diabet Med 1996, 13:S109-S119.
- [3]Yamamoto-Honda R, Osame K, Kitazato H, Shinkai-Goromaru M, Isogawa A, Yoshida Y, Kawzu S, Akanuma Y, Noda M: Insulin secretion and insulin sensitivity in Japanese patients with Type 2 diabetes: a cross-sectional study comparing the homeostasis model assessment-2 (HOMA2) indexes and indexes derived from the oral glucose tolerance test. Diabetology Int 2011, 2:72-78.
- [4]Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC, 4-T Study Group: Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes. N Engl J Med 2007, 357:1716-1730.
- [5]Bretzel RG, Nuber U, Landgraf W, Owens DR, Brandley C, Linn T, Bretzel A, Nuber U, Landgraf W, Owens DR, Brandley C, Linn T: Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomized controlled trial. Lancet 2008, 371:1073-1084.
- [6]Monnier L, Colette C, Rabasa-Lhoret R, Lapinski H, Caubel C, Avignon A, Boniface H: Morning hyperglycemic excursions: a constant failure in the metabolic control of non-insulin-using patients with type 2 diabetes. Diabetes Care 2002, 25(4):737-741.
- [7]Yamamoto-Honda R, Kitazato H, Hashimoto S, Takahashi Y, Yoshida Y, Hasegawa C, Akanuma Y, Noda M: Distribution of blood glucose and correlation between blood glucose and hemoglobin A1c levels in diabetic outpatients. Endocr J 2008, 55(5):913-923.
- [8]DECODE Study Group, on behalf of the European Diabetes Epidemiology Group: Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med 2001, 161:397-405.
- [9]Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F, The ADVANCE Collaborative Group: Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med 2008, 358:2560-2572.
- [10]Ceriello A, Hanefeld M, Leiter L, Monnier L, Moses A, Owens D, Tajima N, Tuomilehto J, for the International Prandial Glucose Regulation (PGR) Study Group: Postprandial glucose regulation and diabetic complications. Arch Intern Med 2004, 164:2090-2095.
- [11]Cavalot F, Pagliarino A, Valle M, Di Martino L, Bonomo K, Massucco P, Anfossi G, Trovati M: Postprandial blood glucose predicts cardiovascular events and all-cause mortality in Type2 Diabetes in a 14-year follow-up: lessons from the San Luigi Gonzaga diabetes study. Diabetes Care 2011, 34:2237-2243.
- [12]Shiraiwa T, Kaneto H, Miyatsuka T, Kato K, Yamamoto K, Kawashima A, Kanda T, Suzuki M, Imano E, Matsuhisa M, Hori M, Yamasaki Y: Postprandial hyperglycemia is a better predictor of the progression of diabetic retinopathy than HbA1c in Japanese type 2 diabetic patients. Diabetes Care 2005, 28:2806-2807.
- [13]Chittari MV, MacTernan P, Bawazeer N, Constantinides K, Ciotola M, O’Hare JP, Kumar S, Ceriello A: Impact of acute hyperglycaemia on endothelial function and retinal vascular reactivity in patients with Type 2 diabetes. Diabet Med 2011, 28:450-454.
- [14]Goto A, Arah OA, Goto M, Terauchi Y, Noda M: Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ 2013, 347:f4533.
- [15]Tsujimoto T, Yamamoto-Honda R, Kajio H, Kishimoto M, Noto H, Hachiya R, Kimura A, Kakei M, Noda M: Vital Signs, QT Prolongation, and Newly Diagnosed Cardiovascular Disease during Severe Hypoglycemia in Type 1 and Type 2 Diabetic Patients. Diabetes Care 2014, 37(1):217-25.
- [16]American Diabetes Association: Standards of Medical Care in Diabetes-2013. Diabetes Care 2013, 36(Supplement):S11-S66.
- [17]Schichtkrull J, Munck O, Jersild M: The M-Value, an index of Blood-Sugar Control in Diabetics. Acta Med Scand 1965, 177:95-102.
- [18]Wójcicki JM: Mathematical descriptions of the glucose control in diabetes therapy. Analysis of the Schlichtkrull “M”-value. Horm Metab Res 1995, 27:1-5.
- [19]Service FJ, Molnar GD, Rosevear JW, Ackerman E, Gatewood LC, William FT: Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes 1970, 19(9):644-655.
- [20]Yuki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, Vähätalo M, Virtamo H, Nikkilä K, Tulokas T, Hulme S, Hardy K, McNulty S, Hänninen J, Levänen H, Lahdenperä S, Lehtonen R, Ryysy L: Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006, 49:442-451.
- [21]Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G: A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administrated as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008, 51:408-416.
- [22]Fonseca V, Gill J, Zhou R, Leahy J: An analysis of early insulin glargine added to metformin with or without sulfonylurea: impact on glycemic control and hypoglycemia. Diabetes, Obesity and Metabolism 2011, 13:814-822.
- [23]Kishimoto M, Noda M: A pilot study of the efficacy of miglitol and sitagliptin for type 2diabetes with a continuous glucose monitoring system and incretin-related markers. Cardiovasc Diabetol 2011, 10:115. BioMed Central Full Text
- [24]Lee A, Patric P, Wishart J, Horowitz M, Morley JE: The effects of miglitol on glucagon-like peptide-1 secretion and appetite sensations in obese type 2 diabetics. Diabetes Obes Metab 2002, 4(5):329-335.
- [25]Sunaga Y, Gonoi T, Shibasaki T, Ichikawa K, Kusama H, Yano H, Seino S: The effects of mitiglinide (KAD-1229), a new anti-diabetic drug, on ATP-sensitive K + channels and insulin secretion: comparison with the sulfonylureas and nateglinide. Eur J Pharmacol 2001, 431(1):199-225.
- [26]Mori Y, Ojima K, Fuujimori Y, Aoyagi I, Kusama H, Yamazaki Y, Kojima M, Shibata N, Itoh Y, Tajima N: Effects of mitiglinide on glucose-induced insulin release into the portal vein and fat-induced triglyceride elevation in prediabetic and diabetic OLETF rats. Endocrine 2006, 29(2):309-15.
- [27]Kim MK, Suk JH, Kwon MJ, Chung HS, Yoon CS, Jun HJ, Ko JH, Kim TK, Lee SH, Oh MK, Rhee BD, Park JH: Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract 2011, 92(3):322-328.
- [28]Yoshihara T, Kumashiro N, Kanazawa Y, Mita T, Sakurai Y, Kawai J, Abe M, Motojima K, Hara K, Yamazaki Y, Kanazawa A, Miwa S, Sato F, Kanno R, Shimizu T, Sakai K, Uchino H, Watada H, Tanaka Y, Kawamori R, Hirose T: Therapeutic efficacy of mitiglinide combined with once daily insulin glargine after switching from multiple daily insulin regimen of aspart insulin and glargine in patients with type 2 diabetes mellitus. Endocr J 2006, 53(1):67-72.
- [29]Kumashiro N, Yoshihara T, Kanazawa Y, Shimizu T, Watada H, Tanaka Y, Fujitani Y, Kawamori R, Hirose T: Long-term effect of combination therapy with mitiglinide and once daily insulin glargine in patients who were successfully switched from intensive insulin therapy in short-term study. Endocr J 2007, 54(1):163-166.
- [30]Takahara M, Shiraiwa T, Kaneto H, Katakami N, Matsuoka TA, Shimomura I: Efficacy of sitagliptin on blood glucose fluctuation in Japanese type 2 diabetic patients with basal-supported oral therapy. Endocr J 2013, 59(12):1131-1136.
- [31]Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C: Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care 2010, 33:1509-1515.
- [32]Kishimoto M, Noda M: Effect of the Addition of Sitagliptin and Miglitol on Insulin-Treated Type 2 Diabetes. Diabetes Ther 2012, 3:11.
- [33]American Diabetes Association: Standards of Medical Care in Diabetes-2014. Diabetes Care 2014, 37:S14-80.
- [34]Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR, American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD): Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012, 35(6):1364-79.