A review of basal insulins

Diabetic Medicine

Volumn 20, Issue 11, 2003, Pages 873-885

  Barnett, Anthony H ^a,b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

Author keywords

Basal insulin; Glycaemic control; Type 1 diabetes; Type 2 diabetes

Indexed keywords

INSULIN DERIVATIVE; INSULIN GLARGINE; ISOPHANE INSULIN; ANTIDIABETIC AGENT; CARRIER PROTEIN; DRUG DERIVATIVE; GLARGINE; INSULIN; INSULIN DETEMIR;

CLINICAL TRIAL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; RISK FACTOR; DELAYED RELEASE FORMULATION; DIABETES MELLITUS; DRUG ADMINISTRATION; INFUSION;

CARRIER PROTEINS; DELAYED-ACTION PREPARATIONS; DIABETES MELLITUS; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INFUSIONS, PARENTERAL; INSULIN; INSULIN, ISOPHANE;

EID: 1542298620     PISSN: 07423071     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1464-5491.2003.00996.x     Document Type: Review

References (62)

1. UKPDS. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352: 837-853.
2. The Diabetes Control and Complications 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: 977-986.
3. Lee W, Zinman B. From insulin to insulin analogs, progress in the treatment of type 1 diabetes. Diabetes Rev 1998; 6: 73-88.
4. Riddle MC. Oral pharmacologic management of type 2 diabetes. Am Fam Physician 1999; 60: 2613-2620.
5. Hirsch I. Intensive treatment of Type 1 diabetes. Med Clin N Am 1998; 82: 689-719.
6. Brange J, Owens DR, Kang S, Volund A. Monomeric insulins and their experimental and clinical implications. Diabetes Care 1990; 13: 923-54.
7. Home P, Alberti K. Insulin therapy. In: Alberti, K, DeFronzo, R, Keen, H, Zimmet, P, eds. International Textbook of Diabetes Mellitus. Chichester: John Wiley & Sons 1992: 831-863.
8. Krayenbuhl C, Rosenberg T. Crystalline protamine insulin. Rep Steno Hosp 1946; 1: 60-73.
9. Vajo Z, Duckworth WC. Genetically engineered insulin analogs: diabetes in the new millenium. Pharmacol Rev 2000; 52: 1-9.
10. Rosskamp RH, Park G. Long-acting insulin analogs. Diabetes Care 1999; 22: B109-B113.
11. Jehle PM, Micheler C, Jehle DR, Breitig D, Boehm BO. Inadequate suspension of neutral protamine Hagendorn (NPH) insulin in pens. Lancet 1999; 354:1604-1607.
12. Cryer P. Hypoglycaemia is the limiting factor in the management of diabetes. Diabetes Metab Res Rev 1999; 15: 42-46.
13. Pickup J, Keen H. Continuous subcutaneous insulin infusion at 25 years: evidence base for the expanding use of insulin pump therapy in type 1 diabetes. Diabetes Care 2002; 25: 593-598.
14. Diabetes Control and Complications Trial Group. Implementation of treatment protocols in the Diabetes Control and Complications Trial. Diabetes Care 1995; 18: 361-376.
15. Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Tauber JP. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes. Diabetes Care 2000; 23: 1232-1235.
16. Saurbrey N, Arnold-Larsen S, Moller-Jensen B, Kuhl C. Comparison of continuous subcutaneous insulin infusion with multiple insulin injections using the NovoPen. Diabet Med 1988; 5: 150-153.
17. Marshall SM, Home PD, Taylor R, Alberti KG. Continuous subcutaneous insulin infusion versus injection therapy: a randomized cross-over trial under usual diabetic clinic conditions. Diabet Med 1987; 4: 521-525.
18. American Diabetes Association (ADA). Continuous subcutaneous insulin infusion (Position Statement). Diabetes Care 2002; 25: S116.
19. Lenhard MJ, Reeves GD. Continuous subcutaneous insulin infusion: a comprehensive review of insulin pump therapy. Arch Intern Med 2001; 161: 2293-2300.
20. Selam JL. External and implantable insulin pumps: current place in the treatment of diabetes. Exp Clin Endocrinol Diabetes 2001; 109: S333-S340.
21. Brange J, Volund A. Insulin analogs with improved pharmacokinetic profiles. Adv Drug Deliv Rev 1999; 35: 307-335.
22. Whittingham JL, Havelund S, Jonassen I. Crystal structure of a prolonged-acting insulin with albumin-binding properties. Biochemistry 1997; 36: 2826-31.
23. Markussen J, Havelund S, Kurtzhals P, Andersen AS, Halstrom J, Hasselager E et al. Soluble, fatty acid acylated insulins bind to albumin and show protracted action in pigs. Diabetologia 1996; 39: 281-288.
24. Kurtzhals P, Havelund S, Jonassen I, Kiehr B, Larsen UD, Ribel U et al. Albumin binding of insulins acylated with fatty acids: characterization of the ligand-protein interaction and correlation between binding affinity and timing of the insulin effect in vivo. Biochem J 1995; 312: 725-731.
25. Heinemann L, Linkeschowa R, Rave K, Hompesch B, Sedalk M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000; 23: 644-649.
26. Bolli GB, Di Marchi RD, Park GD, Pramming S, Koivisto VA. Insulin analogues and their potential in the management of diabetes mellitus. Diabetologia 1999; 42: 1151-1167.
27. Hermansen K, Madsbad S, Perrild H, Kristensen A, Axelsen M. Comparison of the soluble basal insulin analog insulin detemir with NPH insulin, a randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy. Diabetes Care 2001; 24: 296-301.
28. Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000; 49: 2142-2148.
29. Porcellati F, Pampanelli S, Fanelli C, Rossetti P, Torlone E, Costa E et al. Comparison between different regimens of basal insulin supplementation in the prevention of nocturnal hypoglycaemia in intensive treatment of Type 1 diabetes. Diabetologia 2001; 44: A208.
30. Pieber T, Plank J, Goerzer E, Sommer R, Wutte A, Sinner F et al. Duration of action, pharmacodynamic profile and between-subject variability of insulin detemir in subjects with type 1 diabetes. Diabetes 2002; 51: A53.
31. Tunbridge FK, Newens A, Home PD, Davis SN, Murphy M, Burrin JM et al. Double-blind crossover trial of isophane (NPH)-and lente-based insulin regimens. Diabetes Care 1989; 12: 115-119.
32. Gibb DM, Foot AB, May B, Parish H, Strang S, Grant DB et al. Human isophane or lente insulin? A double blind crossover trial in insulin dependent diabetes mellitus. Arch Dis Child 1990; 65: 1334-1337.
33. Zinman B, Ross S, Campos RV, Strack T. Effectiveness of human ultralente versus NPH insulin in providing basal insulin replacement for an insulin lispro multiple daily injection regimen. A double-blind randomized prospective trial. The Canadian Lispro Study Group. Diabetes Care 1999; 22: 603-608.
34. Rosenstock J, Park G, Zimmerman J. Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. US Insulin Glargine (HOE 901) Type 1 Diabetes Investigator Group. Diabetes Care 2000; 23: 1137-1142.
35. Pieber T, Eugene-Jolchine I, Derobert E. Efficacy and safety of HOE901 versus NPH insulin in patients with type 1 diabetes. Diabetes Care 2000; 23: 157-162.
36. Raskin P, Klaff L, Bergenstal R, Halle JP, Donley D, Mecca T. A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care 2000; 23: 1666-1671.
37. Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycemia with insulin glargine in intensive insulin therapy for Type 1 diabetes. Diabetes Care 2000; 23: 639-643.
38. Mohn A, Strang S, Wernicke-Panten K, Lang A, Edge J, Dunger D. Nocturnal glucose control and free insulin levels in children with Type 1 diabetes by use of the long-acting insulin HOE901 as part of a three-injection regimen. Diabetes Care 2000; 23: 557-559.
39. Schober E, Schoenle E, Van Dyk J, Wernicke-Panten K. Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes. Diabetes Care 2001; 24: 2005-2006.
40. Brunner GA, Sendhofer G, Wutte A, Ellmerer M, Sogaard B, Siebenhofer A et al. Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans. Exp Clin Endocrinol Diabetes 2000; 108: 100-105.
41. Selam J, Skeie S, Vague P, Bayer T, Haahr H. Promising results of 6 months treatment with insulin detemir in type 1 diabetic patients. Diabetologia 2001; 44: A15.
42. Vague P, Selam J-L, Skeie S, Leeuw ID, Elte JWF, Haahr H et al. Insulin detemir is associated with more predictable glycemic control and lower risk of hypoglycemia compared to NPH insulin in subjects with type 1 diabetes. Diabetes 2002; 51: A116.
43. Standl E, Roberts A, Lang H. Long-term efficacy and safety of insulin detemir in subjects with type 1 diabetes. Favorable weight development and risk reduction of nocturnal hypoglycemia. Diabetes 2002; 51:A115.
44. Standl E, Roberts A, Lang H. One-year safety and efficacy of insulin detemir in subjects with type 1 diabetes. Favourable weight development and reduced nocturnal hypoglycaemia compared to NPH. Diabetologia 2002; 45: A51.
45. Russell-Jones D, Bolinder J, Simpson R. Lower and more predictable fasting blood glucose and reduced risk of nocturnal hypoglycaemia with once daily insulin detemir versus NPH in subjects with type 1 diabetes. Diabetologia 2002; 45: A51.
46. Yki-Jarvinen H, Kauppila M, Kujansuu E, Lahti J, Marjanen T, Niskanen L et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. N Engl J Med 1992; 327: 1426-1433.
47. Yki-Jarvinen H, Ryysey L, Nikkila K, Tulokas T, Vanamo R, MH. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. Ann Intern Med 1999; 130: 389-396.
48. Riddle M, Schneider J. Beginning insulin treatment of obese patients with evening 70/30 insulin plus glimepiride versus insulin alone. Glimepiride Combination Group. Diabetes Care 1998; 21: 1052-1057.
49. Pugh J, Wagner M, Sawyer J, Ramirez G, Tuley M, Friedberg S. Is combination sulfonylurea and insulin therapy useful in MDDM patients? Diabetes Care 1992; 15: 953-959.
50. Peters A, Davidson M. Insulin plus a sulfonylurea agent for treating type 2 diabetes. Ann Intern Med 1991; 115: 45-53.
51. Taylor R, Davies R, Fox C, Sampson M, Weaver J, Wood L. Appropriate insulin regimes for type 2 diabetes: a multicenter randomized crossover study. Diabetes Care 2000; 23: 1612-1618.
52. Yki-Jarvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 2000; 23: 1130-1136.
53. Rosenstock J, Schwartz S, Clark C, Jr Park G, Donley D, Edwards M. Basal insulin therapy in type 2 diabetes. Diabetes Care 2001; 24: 631-636.
54. European Agency for the Evaluation of Medicinal Products (EMEA). Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues. EMEA report November 15, 2001. Available from: http://www.emea.eu.int/pdfs/human/swp/037201en.pdf.
55. Berti L, Kellerer M, Bossenmaier B, Seffer E, Seipke G, Haring H. The long-acting human insulin analog HOE901: characteristics of insulin signalling in comparison to Asp (B10) and regular insulin. Horm Metab Res 1998; 30: 123-129.
56. Kurtzhals P, Schaffer L, Sorenson A, Kristensen C, Jonassen I, Schmid C et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 2000; 49: 999-1005.
57. Ciaraldi T, Carter L, Seipke G, Mudaliar S, Henry R. Effects of the long acting insulin analog insulin glargine on cultured human skeletal muscle cells: comparisons to insulin and IGF-1. J Clin Endocrinol Metabol 2001; 86: 5838-5847.
58. Stammberger I, Bube A, Durchfeld-Meyer B, Donaubauer H, Troschau G. Evaluation of the carcinogenic potential of insulin glargine (LANTUS) in rats and mice. Int J Toxicol 2002; 21: 171-179.
59. Slawik M, Petersen KG. Effects of basal insulin treatment on IGF-1: glargine vs NPH insulin. Diabetes 2002; 51: A296.
60. American Diabetes Association (ADA). Standards of medical care for patients with diabetes mellitus. ADA Position Statement. Diabetes Care 2001; 24: S33-S43.
61. Riddle M. Timely addition of insulin to oral therapy for Type 2 diabetes. Diabetes Care 2002; 25: 395-396.
62. Rosak C. Insulin analogs: structure, properties and therapeutic indication. Part 2. Long-acting insulin analogs. Internist (Berl) 2001; 42: 1692-1699.