Diabetes Care, Vol 23, Issue 2 157-162, Copyright © 2000 by American Diabetes Association

ARTICLES

Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes

TR Pieber, I Eugene-Jolchine and E Derobert
Department of Internal Medicine, Karl-Franzens University, Graz, Austria. thomas.pieber@kfunigraz.ac.at

OBJECTIVE: HOE 901 (Hoechst Marion Roussel, Frankfurt, Germany) is a biosynthetic insulin with a prolonged action. The aim of this study was to compare the effect of the long-acting insulin analog HOE 901 with NPH insulin regarding glycemic control in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 333 type 1 diabetic patients were enrolled in this multinational parallel group trial. Subjects were randomized either to two different formulations of HOE 901 (the formulations differed only in zinc content) or to NPH insulin. The study was only partially blinded because patients can distinguish HOE 901 (a clear solution) from NPH (a cloudy suspension). In addition to premeal injections of regular insulin, patients received HOE 901 at bedtime or NPH once daily at bedtime or twice daily in the morning and at bedtime. RESULTS: Fasting plasma glucose levels were significantly lower with HOE 901 (-1.88 mmol/l. P = 0.0005) as were fasting self-monitored blood glucose levels (-0.80 mmol/l, P = 0.0020). HbA1c levels also showed a significant reduction with HOE 901 (-0.14%) versus NPH (P = 0.030). The overall frequency of hypoglycemia did not differ, but the frequency of nocturnal hypoglycemia was significantly (P = 0.0037) lower with HOE 901 (36 vs. 55%). However, this effect on nocturnal hypoglycemia was significant only versus NPH once daily not NPH twice daily. The pattern of adverse events and injection site reactions with HOE 901 was similar to that with NPH. CONCLUSIONS: This study indicates that HOE 901 achieves better control of fasting glucose and HbA1c levels over 4 weeks, and HOE 901 has a possible safety benefit in terms of nocturnal hypoglycemia.
CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				S. E. Fineberg, T. T. Kawabata, D. Finco-Kent, R. J. Fountaine, G. L. Finch, and A. S. Krasner Immunological Responses to Exogenous Insulin Endocr. Rev., October 1, 2007; 28(6): 625 - 652. [Abstract] [Full Text] [PDF]

				M. F. Bullano, M. D. Fisher, W. D. Grochulski, L. Menditto, and V. J. Willey Hypoglycemic events and glycosylated hemoglobin values in patients with type 2 diabetes mellitus newly initiated on insulin glargine or premixed insulin combination products Am. J. Health Syst. Pharm., December 15, 2006; 63(24): 2473 - 2482. [Abstract] [Full Text] [PDF]

				F. M Regan and D. B Dunger Use of new insulins in children Arch. Dis. Child. Ed. Pract., August 1, 2006; 91(2): ep47 - ep53. [Full Text] [PDF]

				I. Gallen Review: The evolution of insulin treatment in type 1 diabetes: the advent of analogues The British Journal of Diabetes & Vascular Disease, November 1, 2004; 4(6): 378 - 381. [Abstract] [PDF]

				Update on insulin analogues DTB, October 1, 2004; 42(10): 77 - 80. [Abstract] [Full Text] [PDF]

				K. K. Daugherty Review of Insulin Therapy Journal of Pharmacy Practice, February 1, 2004; 17(1): 10 - 19. [Abstract] [PDF]

				S. Clement, S. S. Braithwaite, M. F. Magee, A. Ahmann, E. P. Smith, R. G. Schafer, and I. B. Hirsch Management of Diabetes and Hyperglycemia in Hospitals Diabetes Care, February 1, 2004; 27(2): 553 - 591. [Full Text] [PDF]

				E. S. Albright, R. Desmond, and D. S.H. Bell Efficacy of Conversion From Bedtime NPH Insulin Injection to Once- or Twice-Daily Injections of Insulin Glargine in Type 1 Diabetic Patients Using Basal/Bolus Therapy Diabetes Care, February 1, 2004; 27(2): 632 - 633. [Full Text] [PDF]

				B. Ahmad Review: Pharmacology of insulin The British Journal of Diabetes & Vascular Disease, January 1, 2004; 4(1): 10 - 14. [Abstract] [PDF]

				I. W. Gallen and C. Carter Prospective Audit of the Introduction of Insulin Glargine (Lantus) Into Clinical Practice in Type 1 Diabetic Patients Diabetes Care, December 1, 2003; 26(12): 3352 - 3353. [Full Text] [PDF]

				A. Hamann, S. Matthaei, C. Rosak, and L. Silvestre A Randomized Clinical Trial Comparing Breakfast, Dinner, or Bedtime Administration of Insulin Glargine in Patients With Type 1 Diabetes Diabetes Care, June 1, 2003; 26(6): 1738 - 1744. [Abstract] [Full Text] [PDF]

				D. E. DeWitt and I. B. Hirsch Outpatient Insulin Therapy in Type 1 and Type 2 Diabetes Mellitus: Scientific Review JAMA, May 7, 2003; 289(17): 2254 - 2264. [Abstract] [Full Text] [PDF]

				A. D. Morris Addressing Dosing Frequency in Diabetes: A Simple Approach to Improving Adherence to Therapy and Clinical Outcomes The Diabetes Educator, May 1, 2003; 29(3): 440 - 453. [PDF]

				P. Rossetti, S. Pampanelli, C. Fanelli, F. Porcellati, E. Costa, E. Torlone, L. Scionti, and G. B. Bolli Intensive Replacement of Basal Insulin in Patients With Type 1 Diabetes Given Rapid-Acting Insulin Analog at Mealtime: A 3-month comparison between administration of NPH insulin four times daily and glargine insulin at dinner or bedtime Diabetes Care, May 1, 2003; 26(5): 1490 - 1496. [Abstract] [Full Text] [PDF]

				P. Vague, J.-L. Selam, S. Skeie, I. De Leeuw, J. W.F. Elte, H. Haahr, A. Kristensen, and E. Draeger Insulin Detemir Is Associated With More Predictable Glycemic Control and Reduced Risk of Hypoglycemia Than NPH Insulin in Patients With Type 1 Diabetes on a Basal-Bolus Regimen With Premeal Insulin Aspart Diabetes Care, March 1, 2003; 26(3): 590 - 596. [Abstract] [Full Text] [PDF]

				N. Younis, H. Soran, and D. Bowen-Jones Insulin glargine: a new basal insulin analogue QJM, November 1, 2002; 95(11): 757 - 761. [Full Text] [PDF]

				D. Putz and U. M. Kabadi Insulin Glargine in Continuous Enteric Tube Feeding Diabetes Care, October 1, 2002; 25(10): 1889 - 1890. [Full Text]

				D. R. Owens Optimising glycaemic control -- the role of long-acting insulin analogues in basal insulin therapy The British Journal of Diabetes & Vascular Disease, September 1, 2002; 2(5): 403 - 406. [Abstract] [PDF]

				C. G. Fanelli, S. Pampanelli, F. Porcellati, P. Rossetti, P. Brunetti, and G. B. Bolli Administration of Neutral Protamine Hagedorn Insulin at Bedtime versus with Dinner in Type 1 Diabetes Mellitus To Avoid Nocturnal Hypoglycemia and Improve Control: A Randomized, Controlled Trial Ann Intern Med, April 2, 2002; 136(7): 504 - 514. [Abstract] [Full Text] [PDF]

				A. W. Norris and L. M.B. Laffel Avoiding Nocturnal Hypoglycemia: Consideration of an Extra Injection at Bedtime Ann Intern Med, April 2, 2002; 136(7): 547 - 549. [Full Text] [PDF]

				Z. Vajo, J. Fawcett, and W. C. Duckworth Recombinant DNA Technology in the Treatment of Diabetes: Insulin Analogs Endocr. Rev., October 1, 2001; 22(5): 706 - 717. [Abstract] [Full Text] [PDF]

				R. Guthrie Is There a Need for a Better Basal Insulin? Clin. Diabetes, April 1, 2001; 19(2): 66 - 70. [Abstract] [Full Text] [PDF]

				J. Rosenstock, S. L. Schwartz, C. M. Clark Jr., G. D. Park, D. W. Donley, and M. B. Edwards Basal Insulin Therapy in Type 2 Diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin Diabetes Care, April 1, 2001; 24(4): 631 - 636. [Abstract] [Full Text]

				H. Moriyama, M. Nagata, K. Fujihira, K. Yamada, S. A. Chowdhury, S. Chakrabarty, Z. Jin, H. Yasuda, H. Ueda, and K. Yokono Treatment With Human Analog (GlyA21, ArgB31, ArgB32) Insulin Glargine (HOE901) Resolves a Generalized Allergy to Human Insulin in Type 1 Diabetes Diabetes Care, February 1, 2001; 24(2): 411 - 412. [Full Text]