Abstract
Background and Objective: Good glycaemic control in patients with diabetes mellitus often requires insulin supplementation therapy. Recent developments of analogue insulin and premixed formulations have increased the therapeutic options for patients who need such therapy. This study aimed to retrospectively clarify appropriate treatment regimens according to age, body mass index (BMI) and duration of diabetes in Japanese patients with type 2 diabetes previously entered in an open-label, randomized trial that compared convenience-oriented biphasic insulin aspart 30 versus multiple injections of insulin aspart with or without NPH insulin.
Methods: Japanese insulin-naïve patients were randomized to receive either biphasic insulin aspart 30 twice daily or insulin aspart three times daily with or without multiple injections of NPH insulin for a treatment period lasting 6 months.
Results: Reduction of glycosylated haemoglobin (HbA1c) at the end of 6 months was not different in the two treatment groups irrespective of BMI, age and duration of diabetes. However, the achievement rate of HbA1c <7.0% was significantly higher in patients with a BMI <25 kg/m2 in the multiple-injection group and tended to be higher in patients with a diabetes duration <10 years in the twice-daily injection group.
Conclusion: Twice-daily injections of biphasic insulin aspart 30 may be more suitable for obese patients whereas multiple injections of insulin aspart with or without NPH insulin may be preferable for those with a longer duration of diabetes.
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References
Diabetes Control and Complication Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86
Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103–17
UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS33). Lancet 1998; 352: 837–53
De Witt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA 2003; 289: 2254–64
Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers. Diabetes Care 2005; 28: 2673–9
Hirao K, Arai K, Yamauchi M, et al., for the Japan Diabetes Clinical Data Management Study Group. Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11). Diabetes Res Clin Pract 2008; 79: 171–6
Kuzuya T, Nakagawa S, Satoh J, et al., and 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. Diabetes Res Clin Pract 2002; 55: 65–85
Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications: part 1. Diagnosis and classification of diabetes: provisional report of a WHO consultation. Diabetes Med 1998; 15: 539–53
Tanaka K, Moriya T, Kanamori A, et al. Analysis and a long-term follow up of ketosis-onset Japanese NIDDM patients. Diabetes Res Clin Pract 1999; 44: 137–46
Kobayashi M, Yamazaki K, Hirao K, et al. The status of diabetes control and antidiabetic drug therapy in Japan: a cross-sectional survey of 17 000 patients with diabetes mellitus (JDDM 1). Diabetes Res Clin Pract 2006; 73: 198–204
UK Prospective Diabetes Study 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study Group. Diabetes 1995; 44: 1249–58
Roder ME, Dinesen B, Hartling SG, et al. Intact proinsulin and beta-cell function in lean and obese subjects with and without type 2 diabetes. Diabetes Care 1999; 22: 609–14
Acknowledgements
This study (JDDM 18) was supported by a grant from the Japan Diabetes Foundation. The authors have no potential conflicts of interest that are directly relevant to the content of this study.
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Appendix
The following members of JDDM participated in this study (in alphabetical order): Dr Nobuyuki Abe (Internal Medicine Abe Clinic), Dr Kotaro Iemitsu (Konandai Iemitsu Clinic), Dr Koichi Iwasaki (Iwasaki Internal Medicine Clinic), Dr Koichi Kawai (Kawai Clinic), Dr Shinichi Kuribayashi (Misaki Internal Medicine Clinic), Dr Gendai Lee (Lee Internal Medicine Clinic), Dr Hajime Maeda (HEC Science Clinic), Dr Kiyokazu Matoba (Matoba Internal Medicine Clinic), Dr Mariko Oishi (Oishi Clinic), Dr Fuminobu Okuguchi (Okuguchi Internal Medicine Clinic), Dr Takeshi Osonoi (Naka Memorial Clinic), Dr Miyoko Saito (Naka Memorial Clinic), Dr Hidekatsu Sugimoto (Sugimoto Clinic), Dr Masato Takagi (Takagi Internal Medicine Clinic), Dr Masahiko Takai (Takai Internal Medicine Clinic), Dr Hiroshi Takeda (Takeda Clinic), Dr Madoka Taguchi (Toshiba Hospital), Dr Noriharu Yagi (Yagi Internal Medicine Clinic), Dr Ritsuko Yamamoto (HEC Science Clinic), Dr Hiroki Yokoyama (Jiyugaoka Yokoyama Internal Medicine Clinic).
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Arai, K., Hirao, K., Yamauchi, M. et al. Influence of BMI, Age and Duration of Diabetes Mellitus on Glycaemic Control with Twice-Daily Injections of Biphasic Insulin Aspart 30 versus Multiple Daily Injections of Insulin Aspart (JDDM 18). Clin. Drug Investig. 30, 35–40 (2010). https://doi.org/10.2165/11530920-000000000-00000
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DOI: https://doi.org/10.2165/11530920-000000000-00000