Efficacy and Safety of Insulin Glulisine in Intensive Insulin Therapy: Bolus Insulin Adjust Nice Control by apiDRA Study (BANDRA Study)

DOI: 10.4236/jdm.2015.51004   PDF   HTML   XML   3,059 Downloads   4,104 Views   Citations


Background: Treatment for postprandial glycemia using rapid-acting insulin analogues sometimes resulted in preprandial hypoglycemia or weight gain. Objective: This study evaluated the efficacy and safety of switching bolus insulin from insulin lispro (Lis) to insulin glulisine (Glu) in patients with inadequately controlled diabetes on intensive insulin therapy with Lis and glargine (Gla). Methods: Seventy-two outpatients with inadequate glycemic control (glycated hemoglobin [HbA1c] 7.0%, glycated albumin [GA] 20%) on intensive insulin therapy comprising Lis and Gla for 24 weeks were enrolled. We switched treatment from Lis to Glu with a stepwise increase in the dose by 1 unit per meal to obtain a GA level of 20% for 24 weeks, and the efficacy and safety were evaluated. Patients’ treatment satisfaction was also evaluated using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) after the treatment. Results: After switching from Lis to Glu, both HbA1c and GA levels significantly lowered from 8.26% ± 0.13% to 7.71% ± 0.13% (P < 0.01) and from 23.9% ± 1.8% to 21.4% ± 1.9% (P < 0.01), respectively. Furthermore, switching from Lis to Glu improved patients’ treatment satisfaction; scores for 7 of the 8 items, such as “satisfaction” and “convenience” were significantly improved (P < 0.001), with no significant change in the scores for “improvement of hypoglycemia” (P = 0.91). Conclusions: Our present study suggests that switching bolus insulin from Lis to Glu by the addition of 1 unit of Glu per meal may be a useful treatment option for patients with inadequate glycemic control receiving intensive insulin therapy with Lis and Gla.

Share and Cite:

Bando, Y. , Shima, K. , Aoki, K. , Kanehara, H. , Hisada, A. , Okafuji, K. , Toya, D. and Tanaka, N. (2015) Efficacy and Safety of Insulin Glulisine in Intensive Insulin Therapy: Bolus Insulin Adjust Nice Control by apiDRA Study (BANDRA Study). Journal of Diabetes Mellitus, 5, 28-35. doi: 10.4236/jdm.2015.51004.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] Stamler, J., Vaccaro, O., Neaton, J.D. and Wentworth, D. (1993) Diabetes, Other Risk Factors, and 12-Yr Cardiovascular Mortality for Men Screened in the Multiple Risk Factor Intervention Trial. Diabetes Care, 16, 434-444. http://dx.doi.org/10.2337/diacare.16.2.434
[2] Haffner, S.M., Lehto, S., Rönnemaa, T., Pyörälä, K. and Laakso, M. (1998) Mortality from Coronary Heart Disease in Subjects with Type 2 Diabetes and in Nondiabetic Subjects with and without Prior Myocardial Infarction. New England Journal of Medicine, 339, 229-234.
[3] The DECODE Study Group (1999) Glucose Tolerance and Mortality: Comparison of WHO and American Diabetes Association Diagnostic Criteria. The DECODE Study Group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative Analysis of Diagnostic Criteria in Europe. Lancet, 354, 617-621.
[4] Tominaga, M., Eguchi, H., Manaka, H., Igarashi, K., Kato, T. and Sekikawa, A. (1999) Impaired Glucose Tolerance Is a Risk Factor for Cardiovascular Disease, But Not Impaired Fasting Glucose. The Funagata Diabetes Study. Diabetes Care, 22, 920-924. http://dx.doi.org/10.2337/diacare.22.6.920
[5] Donahue, R.P., Abbott, R.D., Reed, D.M. and Yano, K. (1987) Postchallenge Glucose Concentration and Coronary Heart Disease in Men of Japanese Ancestry. Honolulu Heart Program. Diabetes, 36, 689-692. http://dx.doi.org/10.2337/diab.36.6.689
[6] 2011 Guideline for Management of PostMeal Glucose in Diabetes. www.idf.org
[7] Holman, R.R., Farmer, A.J., Davies, M.J., et al. (2009) Three-Year Efficacy of Complex Insulin Regimens in Type 2 Diabetes. The New England Journal of Medicine, 361, 1736-1747.
[8] Daikubara, H., Kikuti, T. and Ishida, T. (2011) Shinyaku to Rinsho, 60, 758-765 (in Japanese).
[9] Pouwer, F., Snoek, F.J., van der Ploeg, H.M., Heine, R.J. and Brand, A.N. (1998) A Comparison of the Standard and the Computerized Versions of the Well-Being Questionnaire (WBQ) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Quality of Life Research, 7, 33-38.
[10] Luzio, S., Peter, R., Dunseath, G.J., Mustafa, L. and Owens, D.R. (2008) A Comparison of Preprandial Insulin Glulisine versus Insulin Lispro in People with Type 2 Diabetes over a 12-h Period. Diabetes Research and Clinical Practice, 79, 268-275. http://dx.doi.org/10.1016/j.diabres.2007.11.013
[11] Plank, J., Wutte, A., Brunner, G., Siebenhofer, A., Semlitsch, B., Sommer, R., et al. (2002) A Direct Comparison of Insulin Aspart and Insulin Lispro in Patients with Type 1 Diabetes. Diabetes Care, 25, 2053-2057. http://dx.doi.org/10.2337/diacare.25.11.2053
[12] Homko, C., Deluzio, A., Jimenez, C., Kolaczynski, J.W. and Boden, G. (2003) Comparison of Insulin Aspart and Lispro: Pharmacokinetic and Metabolic Effects. Diabetes Care, 26, 2027-2031.
[13] Garg, S.K., Rosenstock, J. and Ways, K. (2005) Optimized Basal-Bolus Insulin Regimens in Type 1 Diabetes: Insulin Glulisine versus Regular Human Insulin in Combination with Basal Insulin Glargine. Endocrine Practice, 11, 11-17. http://dx.doi.org/10.4158/EP.11.1.11
[14] Becker, R.H. and Frick, A.D. (2008) Clinical Pharmacokinetics and Pharmacodynamics of Insulin Glulisine. Clinical Pharmacokinetics, 47, 7-20. http://dx.doi.org/10.2165/00003088-200847010-00002
[15] Garg, S.K., Ellis, S.L. and Ulrich, H. (2005) Insulin Glulisine: A New Rapid-Acting Insulin Analogue for the Treatment of Diabetes. Expert Opinion on Pharmacotherapy, 6, 643-651.
[16] Becker, R.H., Frick, A.D., Burger, F., Potgieter, J.H. and Scholtz, H. (2005) Insulin Glulisine, a New Rapid-Acting Insulin Analogue, Displays a Rapid Time-Action Profile in Obese Non-Diabetic Subjects. Experimental and Clinical Endocrinology & Diabetes, 113, 435-443.
[17] Heise, T., Nosek, L., Spitzer, H., Heinemann, L., Niemöller, E., Frick, A.D. and Becker, R.H.A. (2007) Insulin Glulisine: A Faster Onset of Action Compared with Insulin Lispro. Diabetes, Obesity and Metabolism, 9, 746-753. http://dx.doi.org/10.1111/j.1463-1326.2007.00746.x
[18] Sakura, N., Omura, M., Oda, E. and Saito, T. (2011) Converse Contributions of Fasting and Postprandial Glucose to HbA1c and Glycated Albumin. Diabetology International, 2, 162-171.
[19] Imai, T., Oikawa, Y. and Shimada, A. (2007) Improved Monitoring of the Hyperglycemic State in Type 1 Diabetes Patients by Use of the Glycoalbumin/HbA1c Ratio. The Review of Diabetic Studies, 4, 44-48. http://dx.doi.org/10.1900/RDS.2007.4.44
[20] Higgins, T., Saw, S., Sikaris, K., Wiley, C.L., Cembrowski, G.C., Lyon, A.W., et al. (2009) Seasonal Variation in Hemoglobin A1c: Is It the Same in both Hemispheres? Journal of Diabetes Science and Technology, 3, 668-671. http://dx.doi.org/10.1177/193229680900300408
[21] DeSalvo, D. and Buckingham, B. (2013) Continuous Glucose Monitoring: Current Use and Future Directions. Current Diabetes Reports, 13, 657-662.

comments powered by Disqus

Copyright © 2020 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.